The Food and Drug Administration has granted accelerated approval for pembrolizumab to treat patients with metastatic non–small cell lung cancer (NSCLC) who have disease that has progressed after other treatments and tumors that express PD-L1. The anti–PD-L1 drug is approved for use with a companion diagnostic, the PD-L1 IHC 22C3 pharmDx test.
Pembrolizumab was approved to treat patients with advanced melanoma in 2014. The effectiveness of the immunotherapy for treating advanced NSCLC was demonstrated among 61 patients enrolled within a larger multicenter, open-label, multipart study, according to an Oct. 2 statement issued by the FDA. These patients had advanced NSCLC that progressed following platinum-based chemotherapy or, if appropriate, targeted therapy for certain genetic mutations (ALK or EGFR), and they each had PD-L1–positive tumors based on the results of the 22C3 pharmDx diagnostic test.
The overall response rate was 41%, and the effect lasted between 2.1 and 9.1 months, the FDA said.
The most common side effects in 550 patients with advanced NSCLC included fatigue, decreased appetite, dyspnea, and cough. Severe immune-mediated side effects occurred involving the lungs, colon, and hormone-producing glands.
Pembrolizumab is marketed as Keytruda by Merck & Co., and the PD-L1 IHC 22C3 pharmDx diagnostic test is marketed by Dako North America Inc.
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