The Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for Keytruda (pembrolizumab; Merck) for the treatment of metastatic non-small cell lung cancer (NSCLC) in patients whose disease has progressed after other treatments and with tumors that express PD-L1. It is approved for use with the PD-L1 IHC 22C3 pharmDx test, the first test designed to detect PD-L1 expression in non-small cell lung tumors.

The approval is based on results from a study of 61 patients with metastatic NSCLC and PD-L1 positive tumors enrolled in a larger, multicenter, open-label, multi-part study following platinum-based chemotherapy or, if appropriate, targeted therapy for genetic mutations ALK or EGFR. Participants received 10mg/kg of Keytruda every two or three weeks; tumors shrank in 41% of patients and the effect lasted between 2.1– 9.1 months.

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Keytruda, a humanized monoclonal antibody, is already indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and if BRAF V600 mutation positive, a BRAF inhibitor. Previously Keytruda was granted Breakthrough Therapy designation and Priority Review status for the new indication.

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