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US FDA accepts Immunomedics' application for breast cancer drug


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US FDA accepts Immunomedics' application for breast cancer drug

The U.S. Food and Drug Administration accepted Immunomedics Inc.'s application seeking approval of its medicine sacituzumab govitecan to treat certain patients with breast cancer.

The Morris Plains, N.J.-based company had refiled the biologics license application for accelerated approval of the drug in December after an initial rejection in January. Immunomedics had said the FDA's complete response letter only focused on chemistry, manufacturing and control, and no new clinical or preclinical data was requested.

The company is seeking approval of the medicine to treat patients with triple-negative breast cancer whose disease has spread to other parts of the body and who did not get better after receiving two previous treatments.

Immunomedics said in a Dec. 26 news release that the FDA is expected to make a decision on the application around June 2, 2020.

Sacituzumab govitecan already has the FDA's fast track and breakthrough therapy designations.