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FDA Grants Accelerated Approval to Sacituzumab Govitecan-hziy for Metastatic TNBC

Efficacy in patients with metastatic triple negative breast cancer was demonstrated in IMMU-132-01 study
24 Apr 2020
Breast Cancer

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

Efficacy was demonstrated in IMMU-132-01 (NCT 01631552), a multicentre, single-arm, trial enrolling 108 patients with metastatic TNBC 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. Tumour 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 v1.1 and response duration. The ORR was 33.3% (95% confidence interval [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, diarrhoea, fatigue, anaemia, vomiting, alopecia, constipation, rash, decreased appetite, and abdominal pain. Sacituzumab govitecan-hziy can also cause severe neutropenia and diarrhoea.

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.

Full prescribing information for TRODELVY is available here.

This indication is approved under accelerated approval based on ORR and response duration. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

FDA granted sacituzumab govitecan-hziy orphan drug, fast track, and breakthrough therapy designation.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System.

For assistance with single-patient INDs for investigational oncology products, healthcare professionals may contact FDA’s Oncology Center of Excellence Project Facilitate.

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