FDA Grants Merck’s Keytruda Extended Label for Lung Cancer

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.