FDA approves Trodelvy for metastatic triple-negative breast cancer
The FDA granted accelerated approval to sacituzumab govitecan-hziy for treatment of certain adults with metastatic triple-negative breast cancer.
The approval of sacituzumab govitecan-hziy (Trodelvy, Immunomedics) applies to use of the agent for patients who received at least two prior therapies for metastatic disease.
Sacituzumab govitecan-hziy is an antibody-drug conjugate directed against Trop-2, a cell-surface protein expressed in many solid cancers.
The FDA based the approval on results of the phase 2, multicenter, single-arm IMMU-132-01 trial, which included 108 patients with metastatic triple-negative breast cancer who received at least two prior treatments for metastatic disease.
The FDA granted accelerated approval to sacituzumab govitecan-hziy for treatment of certain adults with metastatic triple-negative breast cancer.
Patients received sacituzumab govitecan-hziy dosed at 10 mg/kg via IV on days 1 and 8 every 21 days. Treatment continued until disease progression or patients became unable to tolerate therapy.
Investigator-assessed overall response rate and response duration served as primary efficacy outcome measures.
Researchers reported an ORR of 33.3% (95% CI, 24.6-43.1) and a median response duration of 7.7 months (95% CI, 4.9-10.8).
“The approval of Trodelvy — the first antibody-drug conjugate approved specifically for metastatic triple-negative breast cancer, an aggressive cancer with a poor prognosis and few effective therapies — will give clinicians a novel tool for treating patients with this disease,” Aditya Bardia, MD, MPH, director of precision medicine at Center for Breast Cancer at Massachusetts General Hospital Cancer Center, assistant professor of medicine at Harvard Medical School and lead investigator of the IMMU-132-01 trial, said in a press release. “In our trial, Trodelvy demonstrated clinically meaningful responses in patients with difficult-to-treat metastatic triple-negative breast cancer and moves the needle toward better outcomes for patients with metastatic breast cancer.”
The most common adverse events included nausea, neutropenia, diarrhea, fatigue, anemia, vomiting, alopecia, constipation, rash, decreased appetite and abdominal pain. Sacituzumab govitecan-hziy also can cause severe neutropenia and diarrhea, according to FDA.
The FDA previously granted breakthrough therapy, fast track and orphan drug designations to sacituzumab govitecan-hziy for this indication.