Immunomedics resubmits biologics license application to the FDA for sacituzumab govitecan

Immunomedics

3 December 2019 - Immunomedics today announced the resubmission of its biologics license application to the U.S. FDA seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer who have received at least two prior therapies for metastatic disease.

“We appreciate FDA’s guidance during the resubmission period and look forward to working closely with the Agency during the application review,” said Dr. Behzad Aghazadeh, Executive Chairman of Immunomedics. "We are pleased to have reached this important milestone and believe that sacituzumab govitecan, if approved, could become an important new treatment option for patients with late-stage mTNBC.”

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Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Dossier