Astellas Pharma: FDA Grants Priority Review For Enfortumab Vedotin - Quick Facts

(RTTNews) - Seattle Genetics, Inc. (SGEN) and Astellas Pharma Inc. (ALPMY, ALPMY) announced the FDA has accepted the Biologics License Application for enfortumab vedotin and granted priority review for the treatment of patients with locally advanced or metastatic urothelial cancer. The FDA has set a target action date of March 15, 2020.

Enfortumab vedotin is an antibody-drug conjugate composed of an anti-Nectin-4 monoclonal antibody attached to a microtubule-disrupting agent, MMAE, using Seattle Genetics' linker technology. The efficacy of enfortumab vedotin is under investigation.