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FDA Grants Full Approval to Pembrolizumab Plus Chemo for NSCLC

Jason M. Broderick @jasoncology
Published: Monday, Aug 20, 2018

The FDA has granted a full approval to frontline pembrolizumab (Keytruda) for use in combination with standard chemotherapy for patients with metastatic nonsquamous non–small cell lung cancer (NSCLC), based on findings from the phase III KEYNOTE-189 trial.

-positive, and had not received systemic therapy for advanced disease. The trial randomization was 2:1 in favor of the pembrolizumab arm.


In the experimental arm (n = 410), patients received pembrolizumab at a 200-mg fixed dose every 3 weeks plus 500 mg/m2 of pemetrexed plus either 75 mg/m2 of cisplatin or carboplatin (AUC 5) on day 1 every 3 weeks for 4 cycles, followed by 200 mg of pembrolizumab plus 500 mg/m2 of pemetrexed every 3 weeks. The regimen administered to the control group (n = 206) was identical, except that pembrolizumab was replaced with placebo.

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View Conference Coverage
Online CME Activities
TitleExpiration DateCME Credits
Medical Crossfire®: Experts Weigh-In on Emerging Immune Checkpoint Inhibitors and Combination Strategies for Advanced NSCLCNov 30, 20191.5
Burst CME™ – Cancer Summaries and Commentaries: Update from Toronto: Advances in the Treatment of Lung CancersNov 30, 20190.5
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