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FDA reviewing Keytruda for first-line NSCLC

September 7, 2016 7:00 AM UTC

Merck & Co. Inc. (NYSE:MRK) said FDA accepted and granted Priority Review to an sBLA for Keytruda pembrolizumab as a first-line treatment for non-small cell lung cancer in patients with tumors expressing PD-L1. Its PDUFA date is Dec. 24.

Merck also said FDA granted Keytruda breakthrough therapy designation in the indication. The drug is approved as a first-line treatment for advanced melanoma, and has accelerated approval as a second-line therapy for NSCLC in PD-L1 expressors, and for head and neck cancer. ...