Sept. 16 Company Quick Takes: FDA accepts Seattle Genetics' BLA; plus Akynzeo, Purdue, Amplyx, Abbott- Sanofi
FDA to review enfortumab vedotin
Seattle Genetics Inc. (NASDAQ:SGEN) and partner Astellas Pharma Inc. (JASDAQ:4503) said FDA has accepted a BLA and granted Priority Review to enfortumab vedotin for locally advanced or metastatic urothelial cancer. The product, which has breakthrough therapy designation, has a PDUFA date of March 15, 2020 (see "Astellas, Seattle Genetics ADC Could Provide New Option").
China’s NMPA approves Akynzeo for CINV
China’s National Medical Products Administration approved the oral formulation of Akynzeo netupitant/palonosetron from Mundipharma China Pharmaceutical (Beijing, China) for chemotherapy-induced nausea and vomiting. Mundipharma has exclusive marketing, promotion and sales rights to Akynzeo in China; the therapy is a fixed-dose combination of 300 mg netupitant, a NK1R antagonist, and 0.5 mg palonosetron, a selective serotonin (5-HT3) receptor antagonist. Helsinn Healthcare S.A. (Lugano, Switzerland), which holds international development rights, will supply the drug to Mundipharma and co-detail the product in Shanghai...