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.
|CI: confidence interval|
|+: denotes ongoing|
|Overall Response Rate *|
|ORR (95% CI)||27.7% (19.6, 36.9)|
|Response duration *|
|Number of responders||31|
|Median, Months (95% CI)||7.2 (4.7, 8.6)|
|Range, Months||1.4+, 13.7|
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.
Advise the patient to read the FDA-approved patient labeling (Patient Information)
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)].
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)].
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)].
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)].
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)].
Advise women not to breastfeed during treatment and for 1 month after the last dose of TRODELVY [see Use in Specific Populations (8.2)].
Advise females of reproductive potential that TRODELVY may impair fertility [see Use in Specific Populations (8.3)].
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 TRODELVY? TRODELVY is a prescription medicine used to treat adults with: |
|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: |
| How will I receive TRODELVY? |
|What are the possible side effects of TRODELVY? TRODELVY can cause serious side effects, including: |
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|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.|
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