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Thursday, December 26, 2019

FDA accepts Immunomedics’ refiled breast cancer application

The FDA accepts Immunomedics’ (NASDAQ:IMMU) Biologics License Application (BLA) seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease, as a complete class 2 response.
The PDUFA target action date of the resubmitted BLA is June 2, 2020.

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