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 . . .