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FDA Approves Pembrolizumab as First-Line Combination Therapy With Pemetrexed and Carboplatin for Metastatic Nonsquamous NSCLC

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On May 10, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda), an anti–programmed cell death protein 1 (PD-1) therapy, in combination with pemetrexed (Alimta) and carboplatin for the first-line treatment of metastatic nonsquamous non–small cell lung cancer (NSCLC), irrespective of programmed death-ligand 1 (PD-L1) expression.

Under the FDA’s accelerated approval regulations, this indication is approved based on tumor response rate and progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. Read more . . .

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