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FCS Magazine Fall-Winter 2021

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Fall/Winter 2021 1

FALL/WINTER 2021

Main Motivation

Tarralyn Jones’ faith &

mindset help her heal

2 FCS Magazine

Gilead 1/3

TRODELVY attacks mTNBC with an antibody-drug conjugate (ADC)

that binds to Trop-2.1

Based on preclinical data. May not correlate with clinical outcomes.

For adult patients with unresectable locally advanced or

metastatic triple-negative breast cancer (mTNBC) who have

received 2 or more prior systemic therapies, at least one of

them for metastatic disease

A WAY IN

WITH TRODELVY

INDICATION

TRODELVY® (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and

topoisomerase inhibitor conjugate indicated for the treatment of adult patients

with unresectable locally advanced or metastatic triple-negative breast cancer

(mTNBC) who have received two or more prior systemic therapies, at least one

of them for metastatic disease.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: NEUTROPENIA AND DIARRHEA

• Severe or life-threatening neutropenia may occur. Withhold TRODELVY

for absolute neutrophil count below 1500/mm3 or neutropenic fever.

Monitor blood cell counts periodically during treatment. Consider G-CSF

for secondary prophylaxis. Initiate anti-infective treatment in patients

with febrile neutropenia without delay.

• Severe diarrhea may occur. Monitor patients with diarrhea and give ﬂ uid

and electrolytes as needed. Administer atropine, if not contraindicated,

for early diarrhea of any severity. At the onset of late diarrhea, evaluate

for infectious causes and, if negative, promptly initiate loperamide. If

severe diarrhea occurs, withhold TRODELVY until resolved to ≤Grade 1

and reduce subsequent doses.

CONTRAINDICATIONS

• Severe hypersensitivity reaction to TRODELVY.

WARNINGS AND PRECAUTIONS

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur and may

require dose modiﬁ cation. Neutropenia occurred in 61% of patients treated with

TRODELVY. Grade 3-4 neutropenia occurred in 47% of patients. Febrile

neutropenia occurred in 7%. Withhold TRODELVY for absolute neutrophil count

below 1500/mm3 on Day 1 of any cycle or neutrophil count below 1000/mm3 on

Day 8 of any cycle. Withhold TRODELVY for neutropenic fever.

Diarrhea: Diarrhea occurred in 65% of all patients treated with TRODELVY.

Grade 3-4 diarrhea occurred in 12% of patients. One patient had intestinal

perforation following diarrhea. Neutropenic colitis occurred in 0.5% of patients.

Withhold TRODELVY for Grade 3-4 diarrhea and resume when resolved to

≤Grade 1. At onset, evaluate for infectious causes and if negative, promptly

initiate loperamide, 4 mg initially followed by 2 mg with every episode of

diarrhea for a maximum of 16 mg daily. Discontinue loperamide 12 hours after

diarrhea resolves. Additional supportive measures (e.g., ﬂ uid and electrolyte

substitution) may also be employed as clinically indicated. Patients who exhibit

an excessive cholinergic response to treatment can receive appropriate

premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: Serious hypersensitivity

reactions including life-threatening anaphylactic reactions have occurred with

TRODELVY. Severe signs and symptoms included cardiac arrest, hypotension,

wheezing, angioedema, swelling, pneumonitis, and skin reactions.

Hypersensitivity reactions within 24 hours of dosing occurred in 37% of patients.

Grade 3-4 hypersensitivity occurred in 2% of patients. The incidence of

hypersensitivity reactions leading to permanent discontinuation of TRODELVY

was 0.3%. The incidence of anaphylactic reactions was 0.3%. Pre-infusion

medication is recommended. Observe patients closely for hypersensitivity and

infusion-related reactions during each infusion and for at least 30 minutes after

completion of each infusion. Medication to treat such reactions, as well as

emergency equipment, should be available for immediate use. Permanently

discontinue TRODELVY for Grade 4 infusion-related reactions.

GILEAD, TRODELVY, and the GILEAD and TRODELVY logos are trademarks of Gilead Sciences, Inc.

EXPLORE MORE POSSIBILITIES. SCAN TO VISIT TRODELVYHCP.COM.

Fall/Winter 2021 3

Gilead 2/3

For adult patients with unresectable locally advanced or

metastatic triple-negative breast cancer (mTNBC) who have

received 2 or more prior systemic therapies, at least one of

them for metastatic disease

* TRODELVY was studied in ASCENT, a phase 3, randomized, active-controlled, open-label trial. Patients were randomized (1:1) to receive TRODELVY

10 mg/kg as an intravenous infusion on Days 1 and 8 of a 21-day cycle (n=267) or physician's choice of single-agent chemotherapy (n=262), which

included eribulin, vinorelbine, gemcitabine, or capecitabine. Patients were treated until disease progression or unacceptable toxicity. The eﬃ cacy

analysis included Progression-Free Survival (PFS) in BM-neg patients (primary endpoint) by BICR based on RECIST 1.1 criteria, PFS for the full popu-

lation (all patients with and without brain metastases), and Overall Survival (OS) vs single-agent chemotherapy.

• 88% of the full population were BM-neg.1 Results in these patients were similar to those seen in the full population (all randomized patients).2

See exploratory ﬁ ndings for BM-positive population at TRODELVYHCP.com

• 13% of patients in the TRODELVY group in the full population received only 1 prior line of systemic therapy in the metastatic setting (in addition

to having disease recurrence or progression within 12 months of neoadjuvant /adjuvant systemic therapy). Eﬃ cacy results for this subgroup of

patients were consistent with those who had received at least 2 prior lines in the metastatic setting1

Nausea and Vomiting: Nausea occurred in 66% of all patients treated with

TRODELVY and Grade 3 nausea occurred in 4% of these patients. Vomiting

occurred in 39% of patients and Grade 3-4 vomiting occurred in 3% of these

patients. Premedicate with a two or three drug combination regimen (e.g.,

dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor

antagonist as well as other drugs as indicated) for prevention of chemotherapy-

induced nausea and vomiting (CINV). Withhold TRODELVY doses for Grade 3

nausea or Grade 3-4 vomiting and resume with additional supportive measures

when resolved to Grade ≤1. Additional antiemetics and other supportive

measures may also be employed as clinically indicated. All patients should be

given take-home medications with clear instructions for prevention and

treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1

Activity: Patients homozygous for the uridine diphosphate-glucuronosyl

transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile

neutropenia, and anemia and may be at increased risk for other adverse

reactions with TRODELVY. The incidence of Grade 3-4 neutropenia was 67% in

patients homozygous for the UGT1A1*28, 46% in patients heterozygous for the

UGT1A1*28 allele and 46% in patients homozygous for the wild-type allele. The

incidence of Grade 3-4 anemia was 25% in patients homozygous for the

UGT1A1*28 allele, 10% in patients heterozygous for the UGT1A1*28 allele, and

11% in patients homozygous for the wild-type allele. Closely monitor patients

with known reduced UGT1A1 activity for adverse reactions. Withhold or

permanently discontinue TRODELVY based on clinical assessment of the onset,

duration and severity of the observed adverse reactions in patients with

evidence of acute early-onset or unusually severe adverse reactions, which may

indicate reduced UGT1A1 function.

Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause

teratogenicity and/or embryo-fetal lethality when administered to a pregnant

woman. TRODELVY contains a genotoxic component, SN-38, and targets rapidly

dividing cells. Advise pregnant women and females of reproductive potential of

the potential risk to a fetus. Advise females of reproductive potential to use

eﬀ ective contraception during treatment with TRODELVY and for 6 months after

the last dose. Advise male patients with female partners of reproductive

potential to use eﬀ ective contraception during treatment with TRODELVY and

for 3 months after the last dose.

ADVERSE REACTIONS

In the ASCENT study (IMMU-132-05), the most common adverse reactions

(incidence ≥25%) were fatigue, neutropenia, diarrhea, nausea, alopecia, anemia,

constipation, vomiting, abdominal pain, and decreased appetite. The most

frequent serious adverse reactions (SAR) (>1%) were neutropenia (7%),

diarrhea (4%), and pneumonia (3%). SAR were reported in 27% of patients, and

5% discontinued therapy due to adverse reactions. The most common Grade 3-4

lab abnormalities (incidence ≥25%) in the ASCENT study were reduced

neutrophils, leukocytes, and lymphocytes.

DRUG INTERACTIONS

UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of

UGT1A1 may increase the incidence of adverse reactions due to potential

increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors

with TRODELVY.

UGT1A1 Inducers: Exposure to SN-38 may be substantially reduced in patients

concomitantly receiving UGT1A1 enzyme inducers. Avoid administering UGT1A1

inducers with TRODELVY.

BICR=blinded, independent, central review; CI=conﬁ dence interval; HR=hazard ratio; OS=Overall Survival; PFS=Progression-Free Survival; RECIST=Response Evaluation Criteria in Solid Tumors.

TRODELVY IMPROVED

SURVIVAL IN 2L+ mTNBC

In the phase 3 ASCENT trial*

References: 1. TRODELVY [package insert]. Foster City, CA: Gilead Sciences,

Inc.; April 2021. 2. Data on ﬁ le. Gilead Sciences, Inc. 2021.

Please see Brief Summary of full Prescribing Information, including

BOXED WARNING, on the next page.

PROVEN SURVIVAL BENEFIT

12.1 months with TRODELVY (range: 10.7–14.0) (n=235) vs

6.7 months with single-agent chemotherapy (range: 5.8–7.7) (n=233);

95% CI, HR: 0.48 (0.38–0.59) P<.0001

5.6 months with TRODELVY (range: 4.3–6.3) (n=235) vs

1.7 months with single-agent chemotherapy (range: 1.5–2.6) (n=233);

95% CI, HR: 0.41 (0.32–0.52) P<.0001

In the full population1*

• Median PFS was 4.8 months for TRODELVY (range: 4.1–5.8) (n=267)

vs 1.7 months with single-agent chemotherapy (range: 1.5–2.5)

(n=262); 95% CI, HR: 0.43 (0.35–0.54) P<.0001

In the full population1*

• Median OS was 11.8 months for TRODELVY (range: 10.5–13.8) (n=267)

vs 6.9 months with single-agent chemotherapy (range: 5.9–7.6) (n=262);

95% CI, HR: 0.51 (0.41–0.62) P<.0001

3X LONGER

MEDIAN PFS

than single-agent chemotherapy

1 YEAR

MEDIAN OS

PROVEN SURVIVAL BENEFIT

12.1 months with TRODELVY (range: 10.7–14.0) (n=235) vs

6.7 months with single-agent chemotherapy (range: 5.8–7.7) (n=233);

95% CI, HR: 0.48 (0.38–0.59) P<.0001

5.6 months with TRODELVY (range: 4.3–6.3) (n=235) vs

1.7 months with single-agent chemotherapy (range: 1.5–2.6) (n=233);

95% CI, HR: 0.41 (0.32–0.52) P<.0001

In the full population1*

• Median PFS was 4.8 months for TRODELVY (range: 4.1–5.8) (n=267)

vs 1.7 months with single-agent chemotherapy (range: 1.5–2.5)

(n=262); 95% CI, HR: 0.43 (0.35–0.54) P<.0001

In the full population1*

• Median OS was 11.8 months for TRODELVY (range: 10.5–13.8) (n=267)

vs 6.9 months with single-agent chemotherapy (range: 5.9–7.6) (n=262);

95% CI, HR: 0.51 (0.41–0.62) P<.0001

3X LONGER

MEDIAN PFS

than single-agent chemotherapy

1 YEAR

MEDIAN OS

In brain metastases-negative

(BM-neg) population2*

In BM-neg

population2*

TRODELVY® (sacituzumab govitecan-hziy) for injection, for intravenous use

Brief Summary of full Prescribing Information. See full Prescribing Information. Rx Only.

WARNING: NEUTROPENIA AND DIARRHEA

• Severe or life-threatening neutropenia may occur. Withhold TRODELVY for absolute neutrophil count

below 1500/mm3 or neutropenic fever. Monitor blood cell counts periodically during treatment. Consider

G-CSF for secondary prophylaxis. Initiate anti-infective treatment in patients with febrile neutropenia

without delay.

• Severe diarrhea may occur. Monitor patients with diarrhea and give fluid and electrolytes as needed.

Administer atropine, if not contraindicated, for early diarrhea of any severity. At the onset of late

diarrhea, evaluate for infectious causes and, if negative, promptly initiate loperamide. If severe diarrhea

occurs, withhold TRODELVY until resolved to ≤ Grade 1 and reduce subsequent doses.

[See Warnings and Precautions and Dosage and Administration]

INDICATIONS AND USAGE

Also seeClinical Studies

TRODELVY (sacituzumab govitecan-hziy) is a Trop-2-directed antibody and topoisomerase inhibitor conjugate indicated

for the treatment of adult patients with:

• Unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior

systemic therapies, at least one of them for metastatic disease.

• Locally advanced or metastatic urothelial cancer (mUC) who have previously received a platinum-containing

chemotherapy and either programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. This

indication is approved under accelerated approval based on tumor response rate and duration of response. Continued

approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

DOSAGE AND ADMINISTRATION

Also seeWarnings and Precautions

Do NOT substitute TRODELVY for or use with other drugs containing irinotecan or its active metabolite SN-38.

The recommended dose of TRODELVY is 10 mg/kg administered as an intravenous infusion once weekly on Days 1 and

Y Y

8 of 21-day treatment cycles. Continue treatment until disease progression or unacceptable toxicity. Do not administer

TRODELVY at doses greater than 10 mg/kg. Administer TRODELVY as an intravenous infusion only. Do not administer as an

intravenous push or bolus.

• First infusion: Administer infusion over 3 hours. Observe patients during the infusion and for at least 30 minutes

following the initial dose, for signs or symptoms of infusion-related reactions.

• Subsequent infusions

: Administer infusion over 1 to 2 hours if prior infusions were tolerated. Observe patients during the

infusion and for at least 30 minutes after infusion.

• Premedication: Prior to each dose of TRODELVY, premedication for prevention of infusion reactions and prevention of

chemotherapy-induced nausea and vomiting (CINV) is recommended. Premedicate with antipyretics, H1 and H2 blockers

prior to infusion, and corticosteroids may be used for patients who had prior infusion reactions. Premedicate with a two

or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor antagonist or an NK1 receptor

antagonist, as well as other drugs as indicated).

Dose Modifications for Infusion-related Reactions: Slow or interrupt the infusion rate of TRODELVY if the patient

develops an infusion-related reaction. Permanently discontinue TRODELVY for life-threatening infusion-related reactions.

Dose Modifications for Adverse Reactions: Withhold or discontinue TRODELVY to manage adverse reactions as

described below. Do not re-escalate the TRODELVY dose after a dose reduction for adverse reactions has been made.

Severe Neutropenia

, defined as Grade 4 neutropenia ≥7 days, OR Grade 3 febrile neutropenia (absolute neutrophil count

or ANC <1000/mm3 and fever ≥38.5°C), OR at time of scheduled treatment, Grade 3-4 neutropenia which delays dosing

by 2 or 3 weeks for recovery to ≤ Grade 1:

• At first occurrence, 25% dose reduction and administer granulocyte-colony stimulating factor (G-CSF). At second

occurrence, 50% dose reduction. At third occurrence, discontinue TRODELVY.

• At time of scheduled treatment, if Grade 3-4 neutropenia occurs which delays dosing beyond 3 weeks for recovery to

≤Grade 1, discontinue TRODELVY at first occurrence.

Severe Non-Neutropenic Toxicity

y, defined as Grade 4 non-hematologic toxicity of any duration, OR any Grade 3-4 nausea,

y,y

vomiting or diarrhea due to treatment that is not controlled with antiemetics and anti-diarrheal agents, OR other Grade 3-4

non-hematologic toxicity persisting >48 hours despite optimal medical management, OR at time of scheduled treatment,

Grade 3-4 non-neutropenic hematologic or non-hematologic toxicity, which delays dose by 2 or 3 weeks for recovery to

≤Grade 1:

• At first occurrence, 25% dose reduction. At second occurrence, 50% dose reduction. At third occurrence, discontinue

TRODELVY.

• In the event of Grade 3-4 non-neutropenic hematologic or non-hematologic toxicity, which does not recover to ≤Grade 1

within 3 weeks, discontinue TRODELVY at first occurrence.

CONTRAINDICATIONS

Also seeWarnings and Precautions

TRODELVY is contraindicated in patients who have experienced a severe hypersensitivity reaction to TRODELVY.

WARNINGS AND PRECAUTIONS

Also seeBOXED WARNING, Dosage and Administration, Contraindications, Clinical Pharmacology, Nonclinical

Toxicology, andUse in Specific Populations

Neutropenia: Severe, life-threatening, or fatal neutropenia can occur in patients treated with TRODELVY. Neutropenia

occurred in 61% of patients treated with TRODELVY. Grade 3-4 neutropenia occurred in 47% of patients. Febrile

neutropenia occurred in 7% of patients. Withhold TRODELVY for ANC below 1500/mm3 on Day 1 of any cycle or neutrophil

count below 1000/mm3 on Day 8 of any cycle. Withhold TRODELVY for neutropenic fever. Dose modifications may be

required due to neutropenia.

Diarrhea:TRODELVY can cause severe diarrhea. Diarrhea occurred in 65% of all patients treated with TRODELVY. Grade 3-4

diarrhea occurred in 12% of all patients treated with TRODELVY. One patient had intestinal perforation following diarrhea.

Neutropenic colitis occurred in 0.5% of patients. Withhold TRODELVY for Grade 3-4 diarrhea at the time of scheduled

treatment administration and resume when resolved to ≤ Grade 1. At the onset of diarrhea, evaluate for infectious causes

and if negative, promptly initiate loperamide, 4 mg initially followed by 2 mg with every episode of diarrhea for a

maximum of 16 mg daily. Discontinue loperamide 12 hours after diarrhea resolves. Additional supportive measures (e.g.,

fluid and electrolyte substitution) may also be employed as clinically indicated. Patients who exhibit an excessive

cholinergic response to treatment with TRODELVY (e.g., abdominal cramping, diarrhea, salivation, etc.) can receive

appropriate premedication (e.g., atropine) for subsequent treatments.

Hypersensitivity and Infusion-Related Reactions: Serious hypersensitivity reactions including life-threatening

anaphylactic reactions have occurred with TRODELVY treatment. Severe signs and symptoms included cardiac arrest,

hypotension, wheezing, angioedema, swelling, pneumonitis, and skin reactions. Hypersensitivity reactions within 24

hours of dosing occurred in 37% of patients treated with TRODELVY. Grade 3-4 hypersensitivity occurred in 2% of patients.

The incidence of hypersensitivity reactions leading to permanent discontinuation of TRODELVY was 0.3%. The incidence of

anaphylactic reactions was 0.3%. Premedication for infusion reactions in patients receiving TRODELVY is recommended.

Have medications and emergency equipment to treat infusion-related reactions, including anaphylaxis, available for

immediate use when administering TRODELVY. Closely monitor patients for hypersensitivity and infusion-related reactions

during each infusion and for at least 30 minutes after completion of each infusion. Permanently discontinue TRODELVY for

Grade 4 infusion-related reactions.

Nausea and Vomiting:TRODELVY is emetogenic. Nausea occurred in 66% of all patients treated with TRODELVY. Grade 3

nausea occurred in 4% of patients. Vomiting occurred in 39% of patients. Grade 3-4 vomiting occurred in 3% of these

patients. Premedicate with a two or three drug combination regimen (e.g., dexamethasone with either a 5-HT3 receptor

antagonist or an NK1 receptor antagonist as well as other drugs as indicated) for prevention of CINV. Withhold TRODELVY

doses for Grade 3 nausea or Grade 3-4 vomiting and resume with additional supportive measures when resolved to

≤Grade1. Additional antiemetics and other supportive measures may also be employed as clinically indicated. All patients

should be given take-home medications with clear instructions for prevention and treatment of nausea and vomiting.

Increased Risk of Adverse Reactions in Patients with Reduced UGT1A1 Activity: Patients homozygous for the

uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28 allele are at increased risk for neutropenia, febrile

neutropenia, and anemia and may be at increased risk for other adverse reactions with TRODELVY. The incidence of

neutropenia and anemia was analyzed in 701 patients who received TRODELVY and had UGT1A1 genotype results. The

incidence of Grade 3-4 neutropenia was 67% in patients homozygous for the UGT1A1*28 (n=87), 46% in patients

heterozygous for the UGT1A1*28 allele (n=301), and 46% in patients homozygous for the wild-type allele (n=313). The

incidence of Grade 3-4 anemia was 25% in patients homozygous for the UGT1A1*28 allele, 10% in patients heterozygous

for the UGT1A1*28 allele, and 11% in patients homozygous for the wild-type allele. Closely monitor patients with known

reduced UGT1A1 activity for adverse reactions. Withhold or permanently discontinue TRODELVY based on onset, duration,

and severity of the observed adverse reactions in patients with evidence of acute early-onset or unusually severe adverse

reactions, which may indicate reduced UGT1A1 enzyme activity.

Embryo-Fetal Toxicity: Based on its mechanism of action, TRODELVY can cause teratogenicity and/or embryo-fetal

lethality when administered to a pregnant woman. TRODELVY contains a genotoxic component, SN-38, and targets

rapidly dividing cells. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise

females of reproductive potential to use effective contraception during treatment with TRODELVY and for 6 months after

the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during

treatment with TRODELVY and for 3 months after the last dose.

ADVERSE REACTIONS

Also seeBOXED WARNING, Warnings and Precautions, and Clinical Studies

The pooled safety population described in the Warnings and Precautions section reflect exposure to TRODELVY as a

single agent in 795 patients from three studies, IMMU-132-01, IMMU-132-05 and IMMU-132-06 which included 366

patients with mTNBC who had received prior systemic chemotherapy for advanced disease and 180 patients with mUC.

Among the 795 patients treated with TRODELVY, the median duration of treatment was 4.1 months (range: 0 to 59 months).

The most common (≥ 25%) adverse reactions were nausea (66%), diarrhea (65%), fatigue (62%), neutropenia (61%),

alopecia (45%), anemia (42%), vomiting (39%), constipation (37%), decreased appetite (34%), rash (32%) and

abdominal pain (28%).

Metastatic Triple-Negative Breast Cancer

The safety of TRODELVY was evaluated in a randomized, active-controlled, open-label trial (ASCENT, IMMU-132-05) in

patients with mTNBC who had previously received a taxane and at least two prior therapies. Patients were randomized

(1:1) to receive either TRODELVY (n=258) or single agent chemotherapy (n=224) and were treated until disease

progression or unacceptable toxicity. For patients treated with TRODELVY, the median duration of treatment was 4.4

months (range: 0 to 23 months). Serious adverse reactions occurred in 27% of patients, and those in > 1% included

neutropenia (7%), diarrhea (4%), and pneumonia (3%). Fatal adverse reactions occurred in 1.2% of patients, including

respiratory failure (0.8%) and pneumonia (0.4%). TRODELVY was permanently discontinued for adverse reactions in 5%

of patients. These adverse reactions (≥1%) were pneumonia (1%) and fatigue (1%). The most frequent (≥5%) adverse

reactions leading to a treatment interruption in 63% of patients were neutropenia (47%), diarrhea (5%), respiratory

infection (5%), and leukopenia (5%). The most frequent (>4%) adverse reactions leading to a dose reduction in 22% of

patients were neutropenia (11%) and diarrhea (5%). G-CSF was used in 44% of patients who received TRODELVY. The

most common adverse reactions (≥25%) were fatigue, neutropenia, diarrhea, nausea, alopecia, anemia, constipation,

vomiting, abdominal pain, and decreased appetite. The most common Grade 3-4 lab abnormalities (≥25%) were

decreased neutrophils (49%), decreased leukocytes (41%), and decreased lymphocytes (31%).

Locally Advanced or Metastatic Urothelial Cancer

The safety of TRODELVY was evaluated in a single-arm, open-label study (TROPHY, IMMU-132-06) in patients (n=113)

with mUC who had received previous platinum-based and anti-PD-1/PD-L1 therapy. Serious adverse reactions occurred in

44% of patients, and those in >1% included infection (18%), neutropenia (12%, including febrile neutropenia in 10%),

acute kidney injury (6%), urinary tract infection (6%), sepsis or bacteremia (5%), diarrhea (4%), anemia, venous

thromboembolism, and small intestinal obstruction (3% each), pneumonia, abdominal pain, pyrexia, and

thrombocytopenia (2% each). Fatal adverse reactions occurred in 3.6% of patients, including sepsis, respiratory failure,

epistaxis, and completed suicide. TRODELVY was permanently discontinued for adverse reactions in 10% of patients. The

most frequent of these adverse reactions was neutropenia (4%, including febrile neutropenia in 2%). The most common

adverse reactions leading to dose interruption in 52% of patients were neutropenia (27%, including febrile neutropenia

in 2%), infection (12%), and acute kidney injury (8%). The most common (>4%) adverse reactions leading to a dose

reduction in 42% of patients were neutropenia (13%, including febrile neutropenia in 3%), diarrhea (11%), fatigue (8%),

and infection (4%). G-CSF was used in 47% of patients who received TRODELVY. The most common adverse reactions

(incidence ≥25%) were diarrhea, fatigue, neutropenia, nausea, any infection, alopecia, anemia, decreased appetite,

constipation, vomiting, rash, and abdominal pain. The most common Grade 3-4 lab abnormalities (≥25%) were

decreased neutrophils (43%), decreased leukocytes (38%), and decreased lymphocytes (35%). Other clinically significant

adverse reactions (≤15%) include: peripheral neuropathy (12%), sepsis or bacteremia (9%), and pneumonia (4%).

DRUG INTERACTIONS

Also seeWarnings and PrecautionsandClinical Pharmacology

UGT1A1 Inhibitors: Concomitant administration of TRODELVY with inhibitors of UGT1A1 may increase the incidence of

adverse reactions due to potential increase in systemic exposure to SN-38. Avoid administering UGT1A1 inhibitors with

TRODELVY.

UGT1A1 Inducers: Exposure to SN-38 may be substantially reduced in patients concomitantly receiving UGT1A1 enzyme

inducers. Avoid administering UGT1A1 inducers with TRODELVY.

USE IN SPECIFIC POPULATIONS:

Also seeWarnings and Precautions, Clinical Pharmacology,and Nonclinical Toxicology

d d

Pregnancy: TRODELVY can cause teratogenicity and/or embryo-fetal lethality when administered to a pregnant woman.

There are no available data in pregnant women to inform the drug-associated risk. Advise pregnant women and females

of reproductive potential of the potential risk to a fetus.

Lactation:There is no information regarding the presence of sacituzumab govitecan-hziy or SN-38 in human milk, the

effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a

breastfed child, advise women not to breastfeed during treatment and for 1 month after the last dose of TRODELVY.

Females and Males of Reproductive Potential:Verify the pregnancy status of females of reproductive potential prior

to initiation. TRODELVY can cause fetal harm when administered to a pregnant woman. Advise females of reproductive

potential to use effective contraception during treatment with TRODELVY and for 6 months after the last dose.

Males: Advise male patients with female partners of reproductive potential to use effective contraception during

treatment with TRODELVY and for 3 months after the last dose.

Infertility: Based on findings in animals, TRODELVY may impair fertility in females of reproductive potential.

Pediatric Use: Safety and effectiveness of TRODELVY have not been established in pediatric patients.

Geriatric Use: Of the patients who received TRODELVY, 264/795 (33%) of all patients were ≥ 65 years old, and 11% were

≥75 years old. No overall differences in safety and effectiveness were observed between these patients and younger patients.

Hepatic Impairment: No adjustment to the starting dose is required when administering TRODELVY to patients with

mild hepatic impairment (bilirubin ≤ 1.5 ULN and AST/ALT < 3 ULN). The safety of TRODELVY in patients with moderate

or severe hepatic impairment has not been established, and no recommendations can be made for the starting dose in

these patients.

See PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Fall/Winter 2021 5

cancer patients has a

hereditary genetic variant1

in1

Imagine knowing more.

Reference: 1. Samadder NJ, Riegert-Johnson D, Boardman L, et al. Comparison of universal genetic testing vs guideline-directed targeted testing for patients with

hereditary cancer syndrome. JAMA Oncol. 2021;7(2):230-237. doi:10.1001/jamaoncol.2020.6252.

6 FCS Magazine

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On the cover: FCS patient Tarralyn Jones.

Photo courtesy of Griffith Photography.

Fall/Winter 2021 7

PHYSICIAN LEADERSHIP

PRESIDENT & MANAGING PHYSICIAN

LUCIO GORDAN, MD

ASSISTANT MANAGING PHYSICIAN

DIRECTOR OF PATIENT ADVOCACY

MICHAEL DIAZ, MD

MEDICAL DIRECTOR OF CLINICAL

RESEARCH OPERATIONS

GUSTAVO FONSECA, MD, FACP

PHYSICIAN DIRECTOR OF COMPLIANCE

JOSE ALEMAR, MD

PHYSICIAN DIRECTOR OF FINANCE

MAEN HUSSEIN, MD

PHYSICIAN DIRECTOR OF QUALITY

JORGE AYUB, MD

EXECUTIVE LEADERSHIP

CHIEF EXECUTIVE OFFICER

NATHAN H. WALCKER

CHIEF OPERATING OFFICER

JASON COE

CHIEF ADMINISTRATIVE OFFICER

JOYCE NELSON

CHIEF FINANCIAL OFFICER

RICH MACCLARY

CHIEF LEGAL OFFICER & GENERAL COUNSEL

NANCY ARDELL

CHIEF PROCUREMENT OFFICER

PAUL CHADWICK

CHIEF COMPLIANCE OFFICER

VALERIE EASTWOOD

PUBLISHED BY

IN PARTNERSHIP WITH

NATHAN H. WALCKER,

CHIEF EXECUTIVE OFFICER:

Everything we do at FCS is

centered on the patients who

entrust us with their care.

As we enter the final quarter

of this year, I could not be more

pleased with what we have been

able to accomplish amidst the nonstop challenges

of the continuing pandemic and the ever-evolving

oncology care landscape. I took a bit of time recently,

as I concluded my first full year as CEO, to reflect on the

progress we have made and invite you to read the full

article on page 10.

A recent significant development is the opening of our

third Drug Development Unit in Lake Nona. Partnering

with the Sarah Cannon Research Institute, FCS is part of

a network reaching more clinical trial patients than any

single cancer center. Dr. Gus Fonseca, Medical Director

of the Clinical Research Program, shares how important

discoveries will advance more rapidly through this

exciting expansion in Central Florida.

It is rare that a community oncology provider is

able to offer patients the depth and range of the most

advanced and promising cancer treatments — and to

do it with such focus and compassion.

I am grateful to all of our FCS physicians and team

members for your outstanding efforts.

LUCIO GORDAN, MD,

PRESIDENT & MANAGING

PHYSICIAN:

Each day, the work we do is

helping to expand clinical

knowledge and, most importantly,

enhancing the quality of life for our

patients. Our cover story is proof of

that. Tarralyn Jones, a patient cared for by

Dr. David Molthrop and our team in Winter Park, is

able to call herself a three-time cancer survivor, and she

shares her inspiring story with great enthusiasm.

Cancer patients cannot have hope without access to

care, and that is why our advocacy efforts at the local,

statewide and national levels are so integral to our success.

We are proud to have joined with our colleagues

across the country to sponsor a national campaign

designed to reverse the troubling pandemic trend of

Americans delaying critical cancer screenings, resulting

in later stage diagnosis for many.

As partners with the Community Oncology Alliance

Patient Advocacy Network, known as CPAN, we are

engaging patients in sharing their stories with elected

officials so that they more clearly understand the value

of community oncology and the issues that affect quality

and availability.

Our Advocacy Update includes more details on these

vital activities. We remain committed to expanding

partnerships that enable us to enhance the care we

provide to our communities.

Thank you all for your support.

8 FCS Magazine

BY KARI C. BARLOW

‘It’s All About Your Mindset!’

Cancer survivor Tarralyn Jones shares life lessons

indness. Compassion. Sincerity.

Those are the words that come to mind when

Tarralyn Jones thinks about Florida Cancer Specialists

& Research Institute (FCS).

And as a three-time cancer survivor who has spent more than her

fair share of time at the FCS Winter Park clinic, she has earned the

right to have an opinion.

“Every time I go, I am greeted and called by name,” said

Tarralyn, a motivational speaker and the founder of TJ’s Designs

and Events in Winter Park. “They know who you are, and that’s

just excellent customer service. It’s like a family atmosphere.”

Tarralyn first found her way to FCS in 2002 after a

mammogram revealed a complex mass in her right breast. Under

the care of Dr. David Molthrop, she endured eight aggressive

chemotherapy treatments, ultimately reaching a good outcome.

“Dr. Molthrop truly cares about his patients,” she said. “It isn’t

scripted. He truly cares, and there is a level of trust there.”

In the years that followed, Tarralyn and her family — husband

Willie and their three children, Brian, Candace and Christian —

would find out just how much that trust mattered.

In 2008, her breast cancer returned, and it wasn’t easy.

“You’re dealing with the treatment, the hair loss and nausea and

you’re looking at your kids’ faces, and

they’re wondering if you’re going to be

here,” Tarralyn said.

But once again, she sought treatment,

fought hard and moved on with her life.

In 2014, on a frightening day

Tarralyn still recalls vividly, she felt a

little off while driving around town.

“I had a throbbing headache, and I

could not see,” she said. “To this day

I can’t tell you how I got home. … By

the time I did arrive, I couldn’t see how

to put the car in park. The pain was

excruciating.”

PATIENT FEATURE

Dr. David Molthrop, MD

Fall/Winter 2021 9

PATIENT FEATURE

The breast cancer had metastasized to her brain, and she

immediately underwent surgery to remove two tumors.

Seven years later, Tarralyn still has regular follow-up

appointments with Dr. Molthrop, who is in awe of her resilience

and resolve to keep fighting.

“The hardest part for us, as physicians, is recurrence,” said Dr.

Molthrop, who has worked as an oncologist for almost 30 years. “A

lot of times the patients have fought it and gone on with their lives,

and that’s one of the most difficult conversations to have.

“Tarralyn is an easy person to talk to. She steels herself for those

conversations, and that actually makes it easier for us, which is

certainly not the goal.”

Dr. Molthrop said his focus is always on helping patients process

the information he is delivering, whether it’s a first-time diagnosis or

the news of recurring cancer.

“The thing I think is most important is taking what can be a

complicated and emotionally exhausting subject and making it

understandable for the patient,” he said.

For Tarralyn, having Dr. Molthrop’s full support and guidance

over the past 12 years has been a vital piece of her recovery.

“He looks at all the alternatives. He takes the time to research,” she

said. “He listens very closely to find out what side effects I’m having.

That means a lot. When you have sincerity, care and compassion, it

makes a difference and helps you focus on getting better.”

That commitment to her own health and well-being is something

that emerged after Tarralyn’s first cancer diagnosis. Before cancer,

she was busy pouring her energy into

her family.

“We as women wear many hats in our homes,” she recalls. “And I

was neglecting myself.”

Surviving three bouts of cancer opened her eyes to the necessity

of self-care.

“Now I prioritize myself. My appointments, my follow-ups —

I’m first,” says Tarralyn, who urges women to find their own “self-

care diva” deep inside. “I don’t take life for granted. I live life to the

fullest because of cancer.”

That includes her role as the National Events Coordinator for

PFPMA, the Professional Football Players Mothers Association. Her

son Christian plays for the NFL’s Chicago Bears after a standout

career at Florida State University.

Battling cancer, while scary and exhausting, has brought clarity.

She now places a high priority on not only her own health but also

the health of those around her and nurturing the relationships that

help you weather the hard times.

“Let’s be real, sometimes you need someone to hold your

shoulders up!”

When Tarralyn needed support, she relied on her faith and a

strong prayer life, her family and her trusted friends. She also dug

deep within herself and found the will to move forward.

“I do have a stubborn nature,” she says with a laugh. “I’m not

going to buy into being defeated. And it’s all about your mindset.”

As Tarralyn looks to the future, her mission is to encourage

women to put their health first and live every day like the

blessing it is.

“For women who say they’re too busy, take the time to

concentrate on your health by making your appointments, keeping

them and being diligent in follow-up appointments,” she says. “And

remember that early detection is key and can save your life.”

“He listens very closely to find

out what side effects I’m having.

That means a lot. When you have

sincerity, care and compassion, it

makes a difference and helps you

focus on getting better.”

10 FCS Magazine

hen Nate Walcker reflects on

his first year as CEO of Florida

Cancer Specialists & Research

Institute (FCS), he primarily

feels a profound sense of gratitude.

Walcker, who originally joined FCS in

2019 as Chief Financial Officer, took the

helm on Aug. 1, 2020, just five months

into the global pandemic.

“It was exhilarating. It was scary. It was

emotional at times and challenging, but

in a constructive way,” he recalled. “Those

early days forced me to adapt and be

flexible to confront the present-day reality

of leading FCS amidst COVID-19, versus

rolling out our first 100-day strategy and

communicating the broader vision for FCS.”

Looking back, Walcker is quick to

attribute any success he’s had to the skill,

dedication and resolve of the FCS workforce.

“It was the relentless effort of my 4,200

teammates across FCS who really gave their

all,” he said. “It’s truly taken a village.”

Since early 2020, FCS has faced its share

of COVID-19-related obstacles, from

procurement shortages to staffing issues to

the challenge of protecting its vulnerable

patients from the spread of the virus. While

FCS clinics managed to remain open, the

Company had to send home hundreds of

employees to work remotely. In a short span

of time, teammates in all divisions at all

levels were forced to dig in and get creative.

“I couldn’t be prouder of our team —

for showing up, for being flexible and

being able to execute in a fluid, uncertain

environment,” Walcker said. “It took all of

us rowing the boat in the same direction to

deliver for our patients.”

And he points out that FCS hasn’t

simply survived the past 12 to 18 months

— it’s thrived.

In March 2020, the practice opened

its new Lake Mary Cancer Center and

Sarah Cannon Research Institute Drug

Development Unit, a 25,000-square-foot

facility that combines medical oncology

and hematology services and phase one

clinical trial research under one roof.

FCS has launched new cancer centers in

The Villages, Tallahassee, Delray Beach,

Sebring, Estero, Jacksonville and on the

University of Central Florida Cancer

Center Campus in Orlando.

NATHAN H. WALCKER

‘The honor

of a lifetime’

BY KARI C. BARLOW

CEO Nathan H. Walcker talks

first year on the job

Fall/Winter 2021 11

In October 2020, FCS opened a new

oncolytic specialty pharmacy facility in Fort

Myers and, since then, has broken ground

on several new cancer centers in a variety of

locations that include Bradenton, Altamonte

Springs, Clermont and Orange City.

Walcker is especially proud of the FCS

genetics lab expanding to provide in-house

molecular testing, or next generation

sequencing (NGS), for its patients. In

July of this year, the lab began offering

testing to assist in the diagnosis, prognosis

and treatment planning of a wide variety

of cancers, including solid tumors and

hematological malignancies.

“Bringing next generation sequencing

to FCS is an incredible leap forward for

community oncology,” he said. “It allows

us to identify mutations in hundreds of

genes, and really understand each patient’s

unique diagnosis. We’re bringing precision

medicine into the community. Our lab

infrastructure and talent have perfectly

positioned FCS to be a leader in the field.”

These strategic investments — along

with FCS’ ongoing commitment to early

phase drug development and research— are

all part of Walcker’s determination to lead

from the front.

“It goes back to us delivering on our

mission to be at the forefront of oncology

treatment not just across Florida, but

nationally,” he said. “Research can’t just be

in our name. We have to live and breathe it

every day.”

While Walcker sees major growth in

FCS’ future, he plans to take a balanced

approach that aligns with his top three

priorities: 1) placing patients at the

center of everything FCS does, 2) being a

progressive, sought-after employer, and 3)

providing FCS physicians and researchers

with the technology, talent and resources

necessary to break new ground.

“If we do that, everything will fall into

place and good things will come,” he said.

“FCS is already a leader in cancer treatment

… a preeminent brand. Going forward,

what we need to be doing is making sure

we are a destination for cancer care.”

That includes, according to Walcker,

maintaining a sharp focus on being the gold

standard for value-based oncology care.

Since taking over as CEO, Walcker has

often been reminded of a well-known quote

by tennis icon Billie Jean King: “Pressure is

a privilege.”

“I have the tremendous privilege of sitting

in this seat,” he shared. “And every day I

wake up, I need to continue to earn it.”

A former Wall Street investment banker,

Walcker was drawn to FCS because of

a desire to make a lasting impact on

people’s lives and the chance to be part of

a company that is solely focused on taking

care of cancer patients. What he’s witnessed

in the past year has been nothing short of

life changing.

“It has fundamentally shifted my

appreciation of what FCS does for its

patients,” he said. “It’s incredibly complex.

Our physicians, our nurse practitioners,

our teams who show up every day — these

folks are rock stars in my book.”

Walcker said he’s proud to be part of the

Company that gives thousands of people

across Florida access to a best-in-class

provider for cancer care.

“My role at FCS truly is an honor of

a lifetime,” he said. “I could not be more

enthused about what the next year holds

and what we are doing to make sure that

community oncology remains a viable

choice for patients well into the future.”

NATHAN H. WALCKER

“I have the tremendous privilege of sitting in this seat ...

and every day I wake up, I need to continue to earn it.”

12 FCS Magazine

LAKE NONA DDU

Fall/Winter 2021 13

Lake Nona Drug

Development Unit

Expands Access to

Clinical Trials

BY TIM LINAFELT

LAKE NONA DDU

ith the opening of the new, state-of-the-art Sarah Cannon

Drug Development Unit in Lake Nona, Florida Cancer

Specialists & Research Institute (FCS) is part of something

that, at first blush, sounds like it should be impossible: It’s

made the world both bigger and smaller.

Bigger because it has opened an entirely new world of trials,

treatments and care that not so long ago were hard to find and even

harder to reach. Smaller because these treatments are now just down the

road for the millions of people residing in Central Florida — and no

more than a few hours from anywhere in the state.

In collaboration with the University of Central Florida (UCF)

College of Medicine, the Sarah Cannon DDU focuses exclusively

on oncology clinical trials at the earliest phases of research and was

designed to meet the specialized needs of patients seeking advanced

cancer treatment options.

The first patient was treated on a clinical trial at the new unit in

September. The 10,000-square-foot, free-standing facility, located in the

Sarah Cannon | UCF Lake Nona Cancer Center campus, is in the same

location as the FCS Lake Nona clinic, which opened in February and

has already made a big first impression.

“It’s much closer, much faster, yet it comes with the same rigor of the

scientific process,” said Gustavo Fonseca, MD, FACP, Medical Director

of the FCS Clinical Research Program. “We know patients are going to

be treated well, but now they don’t have to go to a much more distant

and difficult-to-reach tertiary care center.”

14 FCS Magazine

The first benefit of the Lake Nona DDU

is apparent as soon as a visitor looks out the

front door. The UCF Lake Nona Medical

Center is mere feet away, and the Orlando

VA Medical Center is not much further.

For many patients, access to their

hospitals — including their trusted doctors,

nurses, specialists and now, novel treatments

— will all be in one centralized location.

That sure beats the stress of road trips,

airports and hotels.

“There is more available that is closer

to home,” said FCS Director of Clinical

Research Bucky Jones-Lombard. “Which is

what the whole focus of FCS is — bringing

care to the patient, rather than the patient

having to come to the care.”

More than that, though, patients who

visit the Lake Nona DDU will have the

opportunity to experience the potentially

lifesaving benefits offered from clinical

trials and research.

Specifically, the facility will offer

qualifying patients the chance to participate

in Phase I trials. That, both Dr. Fonseca

and Jones-Lombard said, is what really sets

the Lake Nona DDU apart.

“It’s a great setting for Sarah Cannon’s

early-phase research program,”

Jones-Lombard said.

Fonseca, who joined FCS in 2013 and

was appointed to his current post earlier

this year, recalled a time when patients who

wanted to participate in such trials were

forced to travel to all corners of the country

— often New York, Boston or Houston.

And once they got to those faraway

places, they might often find themselves in

a fierce competition for time and attention.

“Those were almost the only sites in the

whole country that were getting to try new

drugs and new opportunities for patients,”

Fonseca said. “So you’d have to get on

an airplane.

“Now, you can have the same access to

the same medications at the same time.”

Fonseca is particularly excited about

the potential for advancement in targeted

therapies — drugs that are tuned to address

specific cancer molecules, which might

provide a more tailored and effective course

of action.

“Instead of the old days where we used

to say, ‘OK, you’ve got lung cancer. We’ve

got three (chemotherapies), we’re going to

choose two and give them to you,’ now we

are a lot more specific,” Fonseca said.

“We diagnose, then we figure out what

Fall/Winter 2021 15

LAKE NONA DDU

mutation a patient may have, and then,

depending on what mutation they

have, we give them the specific drugs.

Through our partnership with Sarah

Cannon, we’ve had those exact clinical

trials here in Florida. And all of these

are compounds that, three years ago,

didn’t exist.”

Still, beyond all the trials and

treatments and medical advances to

come, Fonseca is most proud of what

the Lake Nona DDU represents —

FCS’ steadfast commitment to patients

and their families.

“We at FCS are ready to take that

responsibility that is entrusted to us

by the patients and their families and

make sure that they’re taken care of

with the utmost technical and medical

know-how in order to make their

circumstances the most successful

possible,” he said.

The Lake Nona DDU is led by

Cesar Augusto Perez, MD, a

recognized expert in Phase

1 oncology research who

has dedicated his career to

translational oncology. Dr. Perez

most recently served as an

Associate Professor of Medicine

at the University of Miami where

he also was one of the leaders

for Phase 1 oncology clinical

research. He was previously an

Assistant Professor of Medicine

at the University of Louisville,

where he received the Best Faculty

Teacher Award in 2015 and 2017.

After completing a hematology

and oncology fellowship at the

University of Miami, Dr. Perez

received the Peter A. Cassileth, MD

Award as an outstanding fellow,

and served as Chief Fellow.

Dr. Perez works with a team that

includes Sarah Canon and FCS

research nurses, pharmacists and

patient-support members who

provide patients with access to the

latest research and compassionate

care without needing to travel far

from home.

Meet Cesar

Augusto Perez, MD

PATIENT ADVOCACY

16 FCS Magazine

PATIENT ADVOCACY

BY LUCIO GORDAN, MD

FCS PRESIDENT & MANAGING PHYSICIAN

he COVID-19

pandemic

understandably caused

many people to skip

important cancer screenings

because they were worried about

their safety. In fact, while breast,

colon, prostate and lung cancers

did not stop for COVID-19 in

2020, screenings and treatments

did — dramatically.

A study that I co-authored and was published in

the journal JCO Clinical Cancer Informatics, showed

a considerable drop in cancer screening, diagnosis and

treatment for American seniors and Medicare beneficiaries

in 2020.

The study, which was conducted for the

nonprofit Community Oncology Alliance by Avalere

Health, examined common cancer procedures, including

screenings and infusion therapies, such as chemotherapy,

surgeries and radiation therapy. It found significant

reductions in breast (down 85%), colon (-75%), prostate

(-74%) and lung cancer (-56%) screenings at the first

peak of the pandemic in April 2020, compared with April

2019. Our fellow oncologists say they are already starting

to see the traumatic results as cancers are caught at later

stages requiring more complex treatments, resulting in

higher morbidity, or worse, death.

Hey Florida:

It’s Time to Screen

for Cancer!

Lucio Gordan, MD

Fall/Winter 2021 17

Patti LaBelle

18 FCS Magazine

PATIENT ADVOCACY

In the early days of the pandemic,

shelter-in-place orders and patient concerns

about COVID-19 caused a massive drop in

common, preventative screenings, such as

mammograms and colonoscopies, as well as

the cancer therapies and surgical procedures

that occur as a result. While this reduction

in services was expected as lockdowns took

place, several cancer care providers have

reported first-hand that they have not seen

the complete resumption of services — and

that it will take some time for a year of lost

screenings to be made up.

Thankfully, medical centers, doctors'

offices and screening facilities are now open,

and staff are working hard to keep patients

protected so that people can get screened for

cancer in safe and convenient environments.

Now it’s important for people to maintain

control of their health and connect with a

local clinician to schedule recommended

cancer screenings.

It’s Time to Screen.

Early detection and diagnosis for

common cancers may allow for less

extensive treatment, with fewer side effects

and long-term health issues, and it may

even save lives. Unfortunately, cancer is the

second leading cause of death in the United

States, and Florida has the second highest

cancer burden in the nation. Black adults

have higher death rates than all other racial/

ethnic groups for many cancer types. Cancer

is the leading cause of death for Hispanic

and Latino adults. Social determinants of

health including incomes, health literacy

and physical access to care contribute to

these disparities.

Early cancer detection may save lives.

As we emerge from the pandemic, it’s time

for Floridians to schedule their regular

cancer screenings like mammograms and

colonoscopies.

Patients, caregivers and friends of the

FCS community who have questions about

screenings can visit Time to Screen, a new

FREE resource that helps connect people

to convenient screening locations. We are

committed to safeguarding your health and

well-being, which is why we are excited to

support this effort with CancerCare and

the Community Oncology Alliance —

two trusted national nonprofits leading

this campaign.

The campaign has also partnered with two-

time Grammy award winner and “Godmother

of Soul” Patti LaBelle to help spread the word.

LaBelle is appearing in television, digital and

radio public service announcements as part

of the nationwide effort to remind adults,

especially those over the age of 40, to schedule

doctor recommended regular screenings for six

common cancers: breast, colorectal, cervical,

prostate, lung and skin.

“I’ve learned timing is everything in life,

and right now, it’s time to take control of

your health,” said LaBelle. “I know what it’s

like to lose loved ones far too early to cancer.

Don’t wait until it’s too late. I tell everyone,

‘Honey, it’s time to get screened.’ ”

Now is the time to resume cancer

screenings. You or your loved ones can call

(855) 53-SCREEN or visit TimetoScreen.org

to learn about the benefits of screening and

to find a convenient screening location.

Florida, it’s time to screen!

“I’ve learned timing is everything in life, and right now, it’s

time to take control of your health. I know what it’s like to

lose loved ones far too early to cancer. Don’t wait until it’s

too late. I tell everyone, ‘Honey, it’s time to get screened.’ ”

– Patti LaBelle

Fall/Winter 2021 19

20 FCS Magazine

GILOTRIF IS THE ONLY ORAL,

CHEMO-FREE AGENT

APPROVED FOR METASTATIC

SQUAMOUS NSCLC

PROGRESSING AFTER PLATINUM-BASED

CHEMOTHERAPY, REGARDLESS OF MUTATION STATUS1,2

Visit www.gilotrifhcp.com/squamous-mnsclc to learn more

Please see additional Important Safety Information and Brief Summary

of Prescribing Information on the following pages.

INDICATIONS AND USAGE

• GILOTRIF is indicated for the treatment of patients with

metastatic squamous NSCLC progressing after platinum-

based chemotherapy.

IMPORTANT SAFETY INFORMATION FOR

GILOTRIF® (afatinib) TABLETS

WARNINGS AND PRECAUTIONS

Diarrhea

• GILOTRIF can cause diarrhea which may be severe and

can result in dehydration with or without renal impairment.

In clinical studies, some of these cases were fatal.

• For patients who develop Grade 2 diarrhea lasting more

than 48 hours or Grade 3 or greater diarrhea, withhold

GILOTRIF until diarrhea resolves to Grade 1 or less, and

then resume at a reduced dose.

• Provide patients with an anti-diarrheal agent (e.g.,

loperamide) for self-administration at the onset of diarrhea

and instruct patients to continue anti-diarrheal until loose

stools cease for 12 hours.

Bullous and Exfoliative Skin Disorders

• GILOTRIF can result in cutaneous reactions consisting of

rash, erythema, and acneiform rash. In addition, palmar-

plantar erythrodysesthesia syndrome was observed in

clinical trials in patients taking GILOTRIF.

• Discontinue GILOTRIF in patients who develop life-

threatening bullous, blistering, or exfoliating skin lesions.

For patients who develop Grade 2 cutaneous adverse

reactions lasting more than 7 days, intolerable Grade 2, or

Grade 3 cutaneous reactions, withhold GILOTRIF. When

the adverse reaction resolves to Grade 1 or less, resume

GILOTRIF with appropriate dose reduction.

• Postmarketing cases of toxic epidermal necrolysis (TEN)

and Stevens Johnson syndrome (SJS) have been reported

in patients receiving GILOTRIF. Discontinue GILOTRIF if

TEN or SJS is suspected.

Interstitial Lung Disease

• Interstitial Lung Disease (ILD) or ILD-like adverse reactions

(e.g., lung infiltration, pneumonitis, acute respiratory

distress syndrome, or alveolitis allergic) occurred in

patients receiving GILOTRIF in clinical trials. In some

cases, ILD was fatal. The incidence of ILD appeared to be

higher in Asian patients as compared to white patients.

• Withhold GILOTRIF during evaluation of patients with

suspected ILD, and discontinue GILOTRIF in patients with

confirmed ILD.

Hepatic Toxicity

• Hepatic toxicity as evidenced by liver function tests

abnormalities has been observed in patients taking

GILOTRIF. In 4257 patients who received GILOTRIF across

clinical trials, 9.7% had liver test abnormalities, of which

0.2% were fatal.

• Obtain periodic liver testing in patients during treatment

with GILOTRIF. Withhold GILOTRIF in patients who

develop worsening of liver function. Discontinue

treatment in patients who develop severe hepatic

impairment while taking GILOTRIF.

Gastrointestinal Perforation

• Gastrointestinal (GI) perforation, including fatal cases, has

occurred with GILOTRIF. GI perforation has been reported

in 0.2% of patients treated with GILOTRIF among 3213

patients across 17 randomized controlled clinical trials.

• Patients receiving concomitant corticosteroids,

nonsteroidal anti-inflammatory drugs (NSAIDs), or anti-

angiogenic agents, or patients with increasing age or who

have an underlying history of GI ulceration, underlying

diverticular disease, or bowel metastases may be at an

increased risk of perforation.

• Permanently discontinue GILOTRIF in patients who develop

GI perforation.

Consider GILOTRIF as early as second-line for patients with metastatic

squamous NSCLC who progressed after platinum-based chemotherapy1,2

Not an actual patient

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