FDA has approved Trodelvy (sacituzumab govitecan-hziy) for the treatment of adult patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease.
Patients must have received at least two prior therapies before taking Trodelvy. Trodelvy is the first ADC approved by the FDA specifically for relapsed or refractory metastatic TNBC and is also the first FDA-approved anti-Trop-2 ADC.
Trodelvy, which was granted Breakthrough Therapy Designation and Priority Review, was approved under the FDA Accelerated Approval Program based on the objective response rate and duration of response observed in a single-arm, multicenter phase II study.
“Metastatic triple-negative breast cancer is an aggressive form of breast cancer with limited treatment options. Chemotherapy has been the mainstay of treatment for triple-negative breast cancer. The approval of Trodelvy today represents a new targeted therapy for patients living with this aggressive malignancy,” Richard Pazdur, director of the FDA Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA Center for Drug Evaluation and Research, said in a statement. “There is intense interest in finding new medications to help treat metastatic triple-negative breast cancer. Today’s approval provides patients who’ve already tried two prior therapies with a new option.”
Continued approval may be contingent upon verification of clinical benefit in the confirmatory phase III ASCENT study, which was recently halted by the independent data safety monitoring Committee for compelling evidence of efficacy across multiple endpoints.
“In our trial, Trodelvy demonstrated clinically meaningful responses in patients with difficult-to-treat metastatic TNBC and moves the needle towards better outcomes for patients with metastatic breast cancer,” lead investigator Aditya Bardia, director of Precision Medicine at the Center for Breast Cancer, Massachusetts General Hospital Cancer Center, and assistant professor of Medicine at Harvard Medical School, said in a statement.
In the single-arm phase II study, Trodelvy demonstrated an ORR of 33.3% (95% CI: 24.6, 43.1) and a median DoR of 7.7 months (95% CI: 4.9, 10.8), as determined by local assessment, in 108 adult TNBC patients who had previously received a median of three prior systemic therapies in the metastatic setting (range: 2-10).
