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Pembrolizumab (Keytruda®) Approved as First-Line Option for Lung Cancer

October 25, 2016

Breakthrough therapy

Two weeks ago, we reported that pembrolizumab worked well as first-line treatment for advanced lung cancer patients. Those benefits―which included a 40% reduction in risk of death compared to chemotherapy―led the FDA to grant Breakthrough Therapy Designation and Priority Review to the therapy.

Although the FDA had until December 24 to make a decision, U.S. regulators decided yesterday, two months ahead of schedule, to approve pembrolizumab (Keytruda ®, Merck) as a first-line option for patients with advanced non-small cell lung carcinoma (NSCLC). It’s important to note, however, that this approval is for patients whose tumors have high PD-L1 expression (more than half the cells expressed it) and don’t have any mutations in EGFR or ALK. Pembrolizumab is an anti-PD-1 checkpoint antibody that targets the PD-1/PD-L1 pathway and can help keep immune cells active against cancer.

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