Multimedia Update

FDA Grants Accelerated Approval for Immunomedics’ Trodelvy in Previously-Treated Metastatic Triple-Negative Breast Cancer

First FDA-approved antibody-drug conjugate that targets the Trop-2 antigen

Trodelvy is the first antibody-drug conjugate approved by FDA specifically for the treatment of relapsed or refractory metastatic triple-negative breast cancer

Company to Host Conference Call at 5:00 p.m. Eastern Time

MORRIS PLAINS, N.J., April 23, 2020 (GLOBE NEWSWIRE) --  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 Trodelvy (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.

“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,” stated Aditya Bardia, MD, MPH, Director of Precision Medicine at the Center for Breast Cancer, Massachusetts General Hospital Cancer Center and Assistant Professor of Medicine at Harvard Medical School. Dr. Bardia was 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 towards better outcomes for patients with metastatic breast cancer.”