FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

FDA Grants Merck’s Keytruda Extended Label for Lung Cancer

April 22, 2019
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The FDA granted Merck’s blockbuster immuno-oncology drug Keytruda (pembrolizumab) approval for an expanded label for treatment of non-small cell lung cancer (NSCLC).

The agency’s green light expands the drug’s uses to include the first-line treatment of patients with stage III NSCLC or metastatic NSCLC whose tumors express PD-L1 but have no EGFR or ALK genomic tumor aberrations.

The drug’s new indication makes it “an option for more patients with non-small cell lung cancer, including those for whom combination therapy may not be appropriate,” said Jonathan Cheng, Merck’s vice president of oncology clinical research.

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