FDA grants accelerated approval to sacituzumab govitecan-hziy for metastatic triple negative breast

FDA grants accelerated approval to sacituzumab govitecan-hziy for metastatic triple negative breast cancer

On April 22, 2020, the Food and Drug Administration granted accelerated approval to sacituzumab govitecan-hziy (TRODELVY, Immunomedics, Inc.) for adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease.

Efficacy was demonstrated in IMMU-132-01 (NCT 01631552), a multicenter, single-arm, trial enrolling 108 patients with metastatic triple negative breast cancer (mTNBC) who received at least two prior treatments for metastatic disease. Patients received sacituzumab govitecan-hziy 10 mg/kg intravenously on days 1 and 8 every 21days. Tumor imaging was obtained every 8 weeks, and patients were treated until disease progression or intolerance to therapy.

The primary efficacy outcome measures were investigator assessed overall response rate (ORR) using RECIST 1.1 and response duration. The ORR was 33.3% (95% CI: 24.6, 43.1). The median response duration was 7.7 months (95% CI: 4.9, 10.8).

The most common adverse reactions (≥25% of patients) were nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, rash, decreased appetite, and abdominal pain. Sacituzumab govitecan-hziy can also cause severe neutropenia and diarrhea.

The recommended sacituzumab govitecan-hziy dose is 10 mg/kg administered by intravenous infusion administered on days 1 and 8 every 21 days until disease progression or unacceptable toxicity.

View full prescribing information for TRODELVY.

via FDA.gov