NJ biotech company receives FDA approval for breast cancer drug

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Morris Plains-based Immunomedics, Inc. a biopharmaceutical company specializing in antibody-drug conjugates (ADC), announced Wednesday that the U.S. Food and Drug Administration has approved Trodelv (sacituzumab govitecan-hziy) for the treatment of adult patients with metastatic triple-negative breast cancer (TNBC) who have received at least two prior therapies for metastatic disease.

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’s Accelerated Approval Program based on the objective response rate (ORR) and duration of response (DoR) observed in a single-arm, multicenter Phase 2 study.

Continued approval may be contingent upon verification of clinical benefit in the confirmatory Phase 3 ASCENT study, which was recently halted by the independent Data Safety Monitoring Committee (DSMC) for compelling evidence of efficacy across multiple endpoints.

“The approval of Trodelvy, the first ADC approved specifically for metastatic TNBC, an aggressive cancer with a poor prognosis and few effective therapies, will give clinicians a novel tool for treating patients with this disease,” said Dr. 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.

Bardia was also the lead investigator of the Phase 2 study.

“In our trial, Trodelvy demonstrated clinically meaningful responses in patients with difficult-to-treat metastatic TNBC and moves the needle toward better outcomes for patients with metastatic breast cancer,” Bardia said.

The company recently announced that the Phase 3 confirmatory ASCENT study of Trodelvy in metastatic TNBC, with over 500 patients enrolled, will be stopped early due to compelling efficacy across multiple endpoints, based on the unanimous recommendation of the DSMC. The company said that it remains on track to achieve topline results from the ASCENT study by mid-2020.