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FDA Grants Priority Review for Full Approval of Frontline Pembrolizumab Combo in NSCLC

Jason M. Broderick @jasoncology
Published: Monday, Apr 30, 2018

Roger M. Perlmutter, MD, PhD

Roger M. Perlmutter, MD, PhD
The FDA has granted a priority review to a supplemental biologics license application (sBLA) for frontline pembrolizumab (Keytruda) for use in combination with standard chemotherapy for patients with metastatic nonsquamous non–small cell lung cancer (NSCLC), according to Merck (MSD), the manufacturer of the PD-1 inhibitor. 

The double-blind phase III KEYNOTE-189 study accrued 616 patients with advanced or metastatic nonsquamous NSCLC, regardless of PD-L1 expression. Patients were not EGFR- or ALK-positive, and had not received systemic therapy for advanced disease. The trial randomization was 2:1 in favor of the pembrolizumab arm.

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