ARTICLE | Clinical News

Keytruda regulatory update

January 12, 2017 12:06 AM UTC

FDA accepted and granted Priority Review to an sBLA for Merck's Keytruda pembrolizumab as first-line treatment of metastatic or advanced non-squamous non-small cell lung cancer (NSCLC) in combination with pemetrexed and carboplatin. The pharma is seeking approval of NSCLC regardless of PD-L1 expression and with no EGFR or anaplastic lymphoma kinase (ALK) genomic tumor aberrations. The PDUFA date is May 10...