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 withmetastatic TNBC who had received a median of 5 prior therapies (range, 2 – 12).
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.”
