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FDA Approves Pembrolizumab for PD-L1-Positive Lung Cancer

Dr. Richard Pazdur

Richard Pazdur, MD

The FDA granted an accelerated approval to pembrolizumab (Keytruda) as a treatment for patients with pretreated advanced non­–small cell lung cancer (NSCLC) across all histologies whose tumors express PD-L1. The PD-1 inhibitor was approved along with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test, and is indicated for patients who progressed on or after platinum-containing chemotherapy or EGFR- or ALK-targeted agents in patients harboring those mutations. 

The approval was based on data from the phase I KEYNOTE-001 trial, in which the overall response rate with the drug was 41% (n = 25) among a subgroup of 61 patients with pretreated PD-L1-–positive advanced NSCLC as determined by the 22C3 pharmDx diagnostic test. Response duration ranged from 2.1 to 9.1 months. A survival improvement has yet to be demonstrated in a clincial trial, and the acclerated approval is contingent upon the eventual outcomes of confirmatory studies. Click here to read the full article at

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