Keytruda (pembrolizumab)+ chemotherapy filed as sBLA at FDA to treat first-line metastatic or advanced non-squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression and with no EGFR or ALK genomic tumor aberrations.-Merck Inc.

Merck Inc.,announced that the FDA has accepted for review the supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, plus chemotherapy (pemetrexed plus carboplatin) for the first-line treatment of patients with metastatic or advanced non-squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression and with no EGFR or ALK genomic tumor aberrations. This is the first application for regulatory approval of Keytruda in combination with another treatment. The FDA granted Priority Review with a PDUFA, or target action, date of May 10, 2017. The sBLA will be reviewed under the FDA’s Accelerated Approval program.

The application seeks accelerated approval for Keytruda at a fixed dose of 200 mg administered intravenously every three weeks in combination with pemetrexed 500 mg/m2 administered as an IV infusion over 10 minutes every three weeks, and carboplatin AUC 5 mg/mL/min every three weeks for four cycles. KEYNOTE-021, Part 2, Cohort G, the pivotal cohort that forms the basis of the submission, studied 123 previously untreated patients with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumor aberrations and regardless of PD-L1 expression.