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Immunomedics breast cancer treatment rejected by US FDA

Immunomedics Inc. said the U.S. Food and Drug Administration rejected sacituzumab govitecan as a treatment for an aggressive type of breast cancer.

The Morris Plains, N.J.-based company sought approval for the drug in patients with triple-negative breast cancer that is metastatic, or has spread to other parts of the body and the patients have had two previous treatments for metastatic disease. Immunomedics' biologics license application was evaluated under priority review.

Immunomedics said the FDA's complete response letter only focused on chemistry, manufacturing and control — no new clinical or preclinical data was requested. The company said it will request a meeting with the FDA to help eventually bring sacituzumab govitecan to market.

In 2017, it was estimated that about 150,000 women in the U.S. had metastatic breast cancer, according to the National Cancer Institute.