Loretta Itri, MD of Immunomedics @ImmunomedicsInc discusses the FDA grants accelerated approval for Immunomedics"™ trodelvy in previously-treated metastatic triple-negative breast cancer.
Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced that the U.S. Food and Drug Administration (FDA) has approved Trodelvyâ„¢ (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.1
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.