TRODELVY (Page 5 of 6)

14.2 Locally Advanced or Metastatic Urothelial Cancer

The efficacy of TRODELVY was evaluated in TROPHY (IMMU-132-06; NCT03547973), an single-arm, multicenter trial that enrolled 112 patients with locally advanced or mUC who have received prior treatment with a platinum-containing chemotherapy and either PD-1 or PD-L1 inhibitor. Patients were administered TRODELVY 10 mg/kg as an intravenous infusion on Days 1 and 8 of a 21-day treatment cycle. Prior to the administration of TRODELVY, all patients were treated for prevention of chemotherapy induced nausea, vomiting and infusion reactions. Patients were treated until disease progression or unacceptable toxicity.

The median age was 66 years (range: 33 to 90 years), 78% were male, 74% were White, 3% Asian, 3% Black and 20% unknown. All patients had a baseline Eastern Cooperative Oncology Group (ECOG) performance status of 0 (28%) or 1 (72%). Ninety-six percent of patients had metastatic disease; 67% of patients had visceral metastases, including 34% with liver metastases.

The median number of prior systemic therapies was 3 (range: 1 to 8). Sixty-five percent of patients received prior cisplatin, 21% received prior carboplatin, 13% received both prior cisplatin and carboplatin, and 100% received prior PD-1 or PD-L1 inhibitor. For 34% of patients, the platinum-containing chemotherapy was received in the neoadjuvant/adjuvant setting only. Nine percent of patients received prior enfortumab vedotin.

The major efficacy outcome measures were the objective response rate (ORR) and duration of response (DOR), evaluated by Independent Review Assessment, using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. Table 11 summarizes the efficacy results.

Table 11: Efficacy results for patients with locally advanced or mUC in TROPHY

	TRODELVY(N=112)
CI: confidence interval
+: denotes ongoing
* by independent review assessment
Overall Response Rate *
ORR (95% CI)	27.7% (19.6, 36.9)
Complete response	5.4%
Partial response	22.3%
Response duration *
Number of responders	31
Median, Months (95% CI)	7.2 (4.7, 8.6)
Range, Months	1.4+, 13.7

15 REFERENCES

1. “OSHA Hazardous Drugs.” OSHA. http://www.osha.gov/SLTC/hazardousdrugs/index.html.

16 HOW SUPPLIED/STORAGE AND HANDLING

TRODELVY (sacituzumab govitecan-hziy) for injection is a sterile, off-white to yellowish lyophilized powder in a single-dose vial. Each TRODELVY vial is individually boxed in a carton:

• NDC 55135-132-01 contains one 180 mg vial

Store vials in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of reconstitution. Do not freeze.

TRODELVY is a hazardous drug. Follow applicable special handling and disposal procedures¹.

17 PATIENT COUNSELING INFORMATION

Advise the patient to read the FDA-approved patient labeling (Patient Information)

Neutropenia

Advise patients of the risk of neutropenia. Instruct patients to immediately contact their healthcare provider if they experience fever, chills, or other signs of infection [see Warnings and Precautions (5.1)].

Diarrhea

Advise patients of the risk of diarrhea. Instruct patients to immediately contact their healthcare provider if they experience diarrhea for the first time during treatment; black or bloody stools; symptoms of dehydration such as lightheadedness, dizziness, or faintness; inability to take fluids by mouth due to nausea or vomiting; or inability to get diarrhea under control within 24 hours [see Warnings and Precautions (5.2)].

Hypersensitivity and Infusion-Related Reactions

Inform patients of the risk of serious infusion reactions and anaphylaxis. Instruct patients to immediately contact their healthcare provider if they experience facial, lip, tongue, or throat swelling, urticaria, difficulty breathing, lightheadedness, dizziness, chills, rigors, wheezing, pruritus, flushing, rash, hypotension, or fever that occur during or within 24 hours following the infusion [see Warnings and Precautions (5.3)].

Nausea/Vomiting

Advise patients of the risk of nausea and vomiting. Premedication according to established guidelines with a two or three drug regimen for prevention of chemotherapy-induced nausea and vomiting (CINV) is also recommended. Additional antiemetics, sedatives, and other supportive measures may also be employed as clinically indicated. All patients should receive take-home medications for preventing and treating delayed nausea and vomiting, with clear instructions. Instruct patients to immediately contact their healthcare provider if they experience uncontrolled nausea or vomiting [see Warnings and Precautions (5.4)].

Embryo-Fetal Toxicity

Advise female patients to contact their healthcare provider if they are pregnant or become pregnant. Inform female patients of the risk to a fetus and potential loss of the pregnancy [see Use in Specific Populations (8.1)].

Contraception

Advise female patients of reproductive potential to use effective contraception during treatment and for 6 months after the last dose of TRODELVY [see Use in Specific Populations (8.3)].

Advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of TRODELVY [see Use in Specific Populations (8.3)].

Lactation

Advise women not to breastfeed during treatment and for 1 month after the last dose of TRODELVY [see Use in Specific Populations (8.2)].

Infertility

Advise females of reproductive potential that TRODELVY may impair fertility [see Use in Specific Populations (8.3)].

Manufactured by:

Gilead Sciences, Inc.
333 Lakeside Dr.
Foster City, CA 94404, USAU.S. License No. 2258

The Patient Information has been approved by the U.S. Food and Drug Administration.		Revised: 06/2022
Patient Information TRODELVY® (troh-DELL-vee)(sacituzumab govitecan-hziy)for injection, for intravenous use
What is the most important information I should know about TRODELVY?TRODELVY can cause serious side effects, including: Low white blood cell count (neutropenia). Low white blood cell counts are common with TRODELVY and can sometimes be severe and lead to infections that can be life-threatening or cause death. Your healthcare provider should check your blood cell counts during treatment with TRODELVY. If your white blood cell count is too low, your healthcare provider may need to lower your dose of TRODELVY, give you a medicine to help prevent low blood cell count with future doses of TRODELVY, or in some cases may stop TRODELVY. Your healthcare provider may need to give you antibiotic medicines if you develop fever while your white blood cell count is low. Call your healthcare provider right away if you develop any of the following signs of infection during treatment with TRODELVY:
	fever chills cough	shortness of breath burning or pain when you urinate
Severe diarrhea. Diarrhea is common with TRODELVY and can also be severe. Your healthcare provider should monitor you for diarrhea and give you medicine as needed to help control your diarrhea. If you lose too much body fluids (dehydration) your healthcare provider may need to give you fluids and electrolytes to replace body salts. If diarrhea happens later in your treatment, your healthcare provider may check you to see if the diarrhea may be caused by an infection. Your healthcare provider may decrease your dose or stop TRODELVY if your diarrhea is severe and cannot be controlled with anti-diarrheal medicines.Call your healthcare provider right away: the first time that you get diarrhea during treatment with TRODELVY if you have black or bloody stools if you have symptoms of losing too much body fluid (dehydration) and body salts, such as lightheadedness, dizziness or faintness if you are unable to take fluids by mouth due to nausea or vomiting if you are not able to get your diarrhea under control within 24 hours
What is TRODELVY? TRODELVY is a prescription medicine used to treat adults with: a type of breast cancer that is estrogen and progesterone hormone receptor (HR) negative, and human epidermal growth factor receptor 2 (HER2)-negative (also called triple-negative breast cancer). TRODELVY may be used: when your breast cancer has spread to other parts of the body (metastatic) or cannot be removed by surgery, and if you previously received two or more prior treatments, including at least one treatment for metastatic disease. bladder cancer and cancers of the urinary tract that have spread or cannot be removed by surgery. TRODELVY may be used if you have: received a platinum-containing chemotherapy medicine and also received an immunotherapy medicine. It is not known if TRODELVY is safe and effective in people with moderate or severe liver problems.It is not known if TRODELVY is safe and effective in children.
Do not receive TRODELVY if you have had a severe allergic reaction to TRODELVY. Ask your healthcare provider if you are not sure.
Before receiving TRODELVY, tell your healthcare provider about all of your medical conditions, including if you: have been told that you carry a gene for uridine diphosphate-glucuronosyl transferase 1A1 (UGT1A1)*28. People who carry this gene have an increased risk of getting side effects with TRODELVY, especially low white blood cell counts, a fever while your white blood cell count is low, and low red blood cell counts. See “What is the most important information I should know about TRODELVY?“ have liver problems. are pregnant or plan to become pregnant. TRODELVY can harm your unborn baby. Your healthcare provider should check to see if you are pregnant before you start receiving TRODELVY. Females who can become pregnant should use effective birth control during treatment and for 6 months after your last dose of TRODELVY. Talk to your healthcare provider about birth control choices that may be right for you during this time. Males with a female partner who can become pregnant should use effective birth control during treatment and for 3 months after your last dose of TRODELVY. Tell your healthcare provider right away if you or your partner become pregnant during treatment with TRODELVY. are breastfeeding or plan to breastfeed. It is not known if TRODELVY passes into your breastmilk and can harm your baby. Do not breastfeed during treatment and for 1 month after your last dose of TRODELVY. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain medicines may affect the way TRODELVY works.
How will I receive TRODELVY? Your healthcare provider will give you TRODELVY into your vein through an intravenous (IV) line. TRODELVY is given 1 time each week, on Day 1 and on Day 8 of a 21-day treatment cycle. You will receive the first dose of TRODELVY over 3 hours. If you tolerate the first dose well, future doses may be given over 1 to 2 hours. Before each dose of TRODELVY, you will receive medicines to help prevent infusion reactions, and nausea and vomiting. You will be monitored for side effects during and for at least 30 minutes after you receive each infusion of TRODELVY. Your healthcare provider may slow down or temporarily stop your infusion of TRODELVY if you have an infusion-related reaction, or permanently stop TRODELVY if you have a life-threatening infusion-related reaction. Your healthcare provider will decide how long you will continue to receive TRODELVY.
What are the possible side effects of TRODELVY? TRODELVY can cause serious side effects, including: See “What is the most important information I should know about TRODELVY?“ Allergic and infusion-related reactions. Serious allergic reactions can happen during treatment with TRODELVY, including life-threatening allergic reactions, and infusion-related reactions. Tell your healthcare provider or nurse right away if you get any of the following symptoms of an allergic or infusion-related reaction during your infusion of TRODELVY or within 24 hours after you receive a dose of TRODELVY:
	swelling of your face, lips, tongue, or throat hives skin rash, itching, or flushing of your skin fever	difficulty breathing or wheezing lightheadedness, dizziness, feeling faint or pass out chills or shaking chills (rigors)
Nausea and vomiting. Nausea and vomiting are common with TRODELVY and can sometimes be severe. Before each dose of TRODELVY, you will receive medicines to help prevent nausea and vomiting. You should be given medicines to take home with you, along with instructions about how to take them to help prevent and treat any nausea and vomiting after you receive TRODELVY. Call your healthcare provider right away if you have nausea or vomiting that is not controlled with the medicines prescribed for you. Your healthcare provider may decide to decrease your dose or stop TRODELVY if your nausea and vomiting is severe and cannot be controlled with anti-nausea medicines. The most common side effects of TRODELVY include:
	feeling tired or weak hair loss decreased red blood cell count constipation	decreased appetite rash. See “Allergic and infusion-related reactions” above. stomach-area (abdominal) pain or discomfort
TRODELVY may cause fertility problems in females, which could affect your ability to have a baby. Talk to your healthcare provider if fertility is a concern for you.These are not all of the possible side effects of TRODELVY.Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
General information about the safe and effective use of TRODELVY. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your pharmacist or healthcare provider for information about TRODELVY that is written for health professionals.
What are the ingredients in TRODELVY?Active ingredient: sacituzumab govitecan-hziyInactive ingredients: 2-(N-morpholino) ethane sulfonic acid (MES), polysorbate 80 and trehalose dihydrateManufactured by: Gilead Sciences, Inc., 333 Lakeside Dr., Foster City, CA 94404, USAU.S. License No. 2258761115-GS-005For more information about TRODELVY, go to www.TRODELVY.com or call 1-888-983-4668.