FDA Grants Breakthrough Therapy Designation to Immunomedics for Breast Cancer

Morris Plains-based Immunomedics, Inc. announced that its lead investigational antibody-drug conjugate, sacituzumab govitecan, or IMMU-132, has received Breakthrough Therapy Designation from the FDA for the treatment of patients with triple-negative breast cancer (TNBC) who have failed at least 2 prior therapies for metastatic disease.

The Breakthrough Therapy Designation was supported by a Phase 2 study in patients with metastatic TNBC who had received a median of 5 prior therapies (range, 2 – 12).

“We believe Breakthrough Therapy Designation for IMMU-132 further validates this potential therapeutic for patients with TNBC, and we are delighted to receive this important recognition,” commented Cynthia L. Sullivan, President and Chief Executive Officer. “We continue to assess partnering opportunities while completing the scale-up manufacturing and regulatory activities for an international, randomized, controlled, registration trial in TNBC, based on the Special Protocol Assessment agreement that was already granted by the FDA,” she added.

Ms. Sullivan further stated, “IMMU-132 is also in Phase 2 trials in patients with advanced, heavily-pretreated, non-small-cell lung cancer, small-cell lung cancer, and urothelial cancers, where encouraging results have been observed. The Trop-2 receptor targeted by this antibody-drug conjugate has increased expression in a large number of solid cancers. To date, we have enrolled about 300 patients with diverse cancer types.”

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