FDA accepts sBLA for Keytruda (pembrolizumab) in advanced NSCLC

Application based on data from KEYNOTE-010, which showed superior overall survival for patients taking Keytruda compared to chemotherapy in patients with PD-L1 expression on one percent or more of the cancer cells.

“The data from KEYNOTE-010 demonstrated an overall survival benefit in patients with PD-L1 expression on one percent or more of the cancer cells,” said Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “We look forward to working with the FDA over the course of the application review process and remain committed to advancing our broad clinical program for cancers where patients are in need of new options, including lung cancer.”

Keytruda is currently indicated in the US for the treatment of patients with metastatic NSCLC whose tumours express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving Keytruda (pembrolizumab). The NSCLC indication, approved under accelerated approval, was based on tumour response rate and durability of response in patients with PD-L1 expression on 50% or more of the cancer cells. Under accelerated approval, improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

In accordance with the accelerated approval process, the data from KEYNOTE-010 was intended to serve as the confirmatory trial for receiving full approval, establishing the clinical benefit by demonstrating improved survival over standard chemotherapy. Findings from this study were presented at the European Society for Medical Oncology (ESMO) Asia 2015 Congress and published in The Lancet (see news release).