FDA Grants Accelerated Approval to Sacituzumab Govitecan-Hziy for Metastatic Triple-Negative Breast Cancer
On April 22, 2020, the U.S. Food and Drug Administration (FDA) granted accelerated approval (https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-sacituzumab-govitecan-hziy-metastatic-triple-negative-breast-cancer) to sacituzumab govitecan-hziy (Trodelvy®) for adult patients with metastatic triple-negative breast cancer (mTNBC) who received at least two prior treatments.
Efficacy was demonstrated in a multicenter, single-arm trial (IMMU-132-01; NCT01631552) that enrolled 108 patients with mTNBC. Sacituzumab govitecan-hziy was administered at 10 mg/kg via IV on days 1 and 8 every 21 days. Tumor imaging was obtained every eight weeks, and patients were treated until disease progression or they became intolerant to therapy.
The primary efficacy outcome measures were investigator-assessed overall response rate (ORR) using Response Evaluation Criteria in Solid Tumors 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%) in patients were nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, rash, decreased appetite, and abdominal pain. Severe neutropenia and diarrhea were also reported.
The recommended dose is 10 mg/kg administered by IV infusion on days 1 and 8 every 21 days until patients experience disease progression or unacceptable toxicity.
FDA used ORR and response duration to grant accelerated approval. 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. A description of FDA expedited programs is in the Guidance for Industry: Expedited Programs for Serious Conditions—Drugs and Biologics (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/expedited-programs-serious-conditions-drugs-and-biologics).
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 (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm) or by calling 800-FDA-1088.
For assistance with single-patient oncology investigational new drug applications, contact OCE’s Project Facilitate (https://www.fda.gov/about-fda/oncology-center-excellence/project-facilitate) at 240-402-0004 or email OncProjectFacilitate@fda.hhs.gov (mailto:OncProjectFacilitate@fda.hhs.gov).