FDA extends PDUFA for Keytruda monotherapy in first-line NSCLC

Merck & Co. Inc. (NYSE:MRK) said FDA has extended by three months the PDUFA date for an sBLA for Keytruda pembrolizumab as monotherapy for first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients whose tumors express PD-L1 without EGFR or anaplastic lymphoma kinase (ALK) aberrations. The new PDUFA date is April 11, 2019.

Merck said it had submitted to FDA additional data from the Phase III KEYNOTE-042 trial, which constituted a major amendment to the sBLA and prompted the agency to extend its review...