FDA accepts Alecensa sNDA for first-line NSCLC

FDA accepted and granted Priority Review to an sNDA from the Genentech Inc. unit of Roche (SIX:ROG; OTCQX:RHHBY) for Alecensa alectinib (AF802, CH5424802, RG7853, RO5424802) as first-line treatment of anaplastic lymphoma kinase (ALK)-positive advanced or metastatic non-small cell lung cancer (NSCLC). Its PDUFA date is Nov. 30...