FDA grants regular approval to Trodelvy for triple-negative breast cancer
The FDA granted regular approval to sacituzumab govitecan for treatment of certain patients with triple-negative breast cancer.
The approval applies to use of the agent for patients with unresectable locally advanced or metastatic disease who received two or more prior systemic therapies, at least one of which was administered in the metastatic setting.
Sacituzumab govitecan (Trodelvy, Immunomedics) is an antibody-drug conjugate directed against Trop-2, a cell-surface protein expressed in many solid cancers.
Last year, the FDA granted accelerated approval to the agent for patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease.
The agency based the regular approval on results of a confirmatory randomized trial that included 529 patients with unresectable locally advanced or metastatic triple-negative breast cancer relapsed after at least two prior chemotherapies, one of which could be in the neoadjuvant or adjuvant setting if progression occurred within 12 months.
Researchers randomly assigned 267 patients to 10 mg/kg sacituzumab govitecan via IV infusion on days 1 and 8 of 21-day cycles. The other 262 patients received physician’s choice of single-agent chemotherapy. Treatment continued until disease progression or unacceptable toxicity.
PFS assessed by blinded independent centralized review among patients without brain metastases at baseline served as the primary endpoint. Secondary endpoints included PFS for the entire study population, as well as OS.
Among all patients, researchers reported longer median PFS (4.8 months vs. 1.7 months; HR = 0.43; 95% CI, 0.35-0.54) and OS (11.8 months vs. 6.9 months; HR = 0.51; 95% CI, 0.41-0.62) in the sacituzumab govitecan group.
The most common adverse events reported among sacituzumab govitecan-treated patients included nausea, neutropenia, diarrhea, fatigue, alopecia, anemia, vomiting, constipation, rash, decreased appetite and abdominal pain.