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FDA granted Immunomedics breakthrough therapy designation for the company’s investigational antibody drug conjugate for treatment of triple negative breast cancer.
Immunomedics, an antibody-based therapeutics company, announced Feb. 5, 2016 that the company had received breakthrough therapy designation from FDA for an investigational antibody-drug conjugate (ADC) for the treatment of triple negative breast cancer (TNBC).
IMMU-132 (Sacituzumab govitecan) is an investigational treatment for TNBC, a type of breast cancer that does not express progesterone, estrogen, or the HER2 receptor. TNBC is insensitive to most targeted therapies for cancer treatment, such as HER2-directed therapy and endocrine therapies. IMMU-132 was developed by conjugating the moderately-toxic drug, SN-38, site-specifically and at a high ratio of drug to antibody, to a humanized antibody that targets the TROP-2 receptor expressed by many solid cancers.
The ADC was awarded fast-track designation by FDA and is also in Phase II clinical trials for patients with advanced, pretreated, non-small-cell lung cancer, small-cell lung cancer, and urothelial cancers. If approved, IMMU-132 will join eribulin, from Eisai, for the treatment of patients with metastic liosarcoma, and ofatumumab, from Novartis, for the treatment of patients with recurrent or progressive chronic lymphocytic leukemia, both of which have been approved in 2016 for the treatment of cancers.