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TRODELVY

SACITUZUMAB GOVITECAN

Manufacturer: Gilead Sciences

Score: 144.0

Quick Summary

TRODELVY is a Trop-2 directed antibody and topoisomerase inhibitor conjugate used for the treatment of adult patients with locally advanced or metastatic triple-negative breast cancer, hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer, and locally advanced or metastatic urothelial cancer. It has a recommended dose of 10 mg/kg administered as an intravenous infusion once weekly on Days 1 and 8 of 21-day treatment cycles. The drug has warnings for neutropenia and diarrhea, and is contraindicated in patients who have experienced a severe hypersensitivity reaction to TRODELVY. Special population considerations include use in pregnancy, pediatric use, and geriatric use.

Key Clinical Findings and Indications

  • Locally advanced or metastatic triple-negative breast cancer
  • Hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer
  • Locally advanced or metastatic urothelial cancer

Important Safety Information

Warning

Neutropenia and diarrhea

Contraindications

  • Severe hypersensitivity reaction to TRODELVY

Adverse Reactions

  • Neutropenia
  • Diarrhea
  • Nausea
  • Fatigue
  • Alopecia

Dosing Recommendations

General Guidance

Dose modifications for adverse reactions, including neutropenia and non-neutropenic toxicity

Locally advanced or metastatic triple-negative breast cancer

Adult Dose

10 mg/kg once weekly on Days 1 and 8 of 21-day treatment cycles

Pediatric Dose

Hormone receptor-positive, human epidermal growth factor receptor 2-negative breast cancer

Adult Dose

10 mg/kg once weekly on Days 1 and 8 of 21-day treatment cycles

Pediatric Dose

Locally advanced or metastatic urothelial cancer

Adult Dose

10 mg/kg once weekly on Days 1 and 8 of 21-day treatment cycles

Pediatric Dose

Special Population Considerations

Pregnancy

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

Nursing Mothers

Pediatric Use

  • Safety and effectiveness of TRODELVY have not been established in pediatric patients

Geriatric Use

  • No overall differences in safety and effectiveness were observed between patients ≥ 65 years of age and younger patients
  • Higher discontinuation rate due to adverse reactions in patients aged 65 years or older

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