Merck says US FDA accepts its sBLA for Keytruda

US pharma giant Merck & Co said the US Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) for its immuno-therapy Keytruda (pembrolizumab), to include data from a new mid-stage study.

Roger Dansey, senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories, said, “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. 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.”

The trial was a Phase II/ III study designed to evaluate Keytruda compared to chemotherapy based on prospective measurement of PD-L1 expression in previously treated patients with advanced non-small cell lung cancer. Results from the study were published in The Lancet in December 2015.

Data from study showed superior overall survival for patients taking Keytruda compared to chemotherapy in patients with PD-L1 expression on 1% or more of the cancer cells.

Keytruda is currently indicated in the US to treat metastatic melanoma.

Anjali Shukla