Posted by Michael Wonder on 07 Sep 2016
FDA accepts supplemental biologics license application, assigns priority review and grants breakthrough therapy designation to Merck’s Keytruda (pembrolizumab) for first-line treatment of patients with advanced non-small-cell lung cancer
7 September 2016 - Merck has also submitted a marketing authorization application to the EMA for Keytruda in the same patient population.
Merck today announced that the U.S. FDA has accepted for priority review the supplemental biologics license application for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors express PD-L1, with a PDUFA goal date of 24 December 2016. Additionally, the FDA granted breakthrough therapy designation for this indication. Merck has also submitted a marketing authorization application to the EMA for this indication.
The submissions were based on data from the pivotal phase 3 Keynote-024 study, which showed that Keytruda monotherapy resulted in superior progression-free survival as well as overall survival compared with standard chemotherapy in patients with advanced NSCLC whose tumors expressed high levels of PD-L1 (tumor proportion score of 50 percent or more). Based on the results, the trial was stopped early to give patients still on chemotherapy the opportunity to receive Keytruda. Merck filed for approval of Keytruda in the first-line setting at a dose of 200 mg every three weeks, the dose studied in Keynote-024.
