Keytruda pembrolizumab regulatory update

FDA accepted and granted Priority Review to an sBLA from Merck seeking accelerated approval of Keytruda pembrolizumab to treat non-small cell lung cancer (NSCLC). The application covers patients whose disease has progressed on or after platinum-containing chemotherapy or a therapy for EGFR or anaplastic lymphoma kinase (ALK) tumor aberrations. The PDUFA date is Oct. 2. The application is based in part on data from the open-label, U.S. Phase Ib KEYNOTE-001 trial, which showed that Keytruda led to an objective response rate (ORR) of 45.4% in patients with >=50% of tumor cells positive for PD-L1 (see BioCentury, April 27).

Separately, Health Canada granted conditional approval to Keytruda to treat patients with unresectable or metastatic melanoma and disease progression following treatment with Yervoy ipilimumab and, if the patient is BRAF V600 mutation-positive, following a BRAF or MEK inhibitor. Merck launched Keytruda in the country this month. ...