Oct. 2 Company Quick Takes: Merck, Immunovant, PureTech-Ariya, Viscient-Organovo and Durect
China approves Keytruda monotherapy for 1L NSCLC
China's National Medical Products Administration approved PD-1 inhibitor Keytruda pembrolizumab from Merck & Co. Inc. (NYSE:MRK) as a monotherapy for first-line treatment of locally advanced or metastatic non-small cell lung cancer in patients whose tumors express PD-L1. NMPA also approved companion diagnostic PD-L1 IHC 22C3 pharmDx assay from Agilent Technologies Inc. (NYSE:A).
Separately, FDA accepted an NDA from Merck for Dificid fidaxomicin oral suspension and an sNDA for Dificid tablets and oral suspension for Clostridium difficile infection in children age six months and older. Both applications have Priority Review and a PDUFA date of Jan. 24...