FDA grants early approval for Merck's Keytruda for untreated lung cancer

The US Food and Drug Administration has granted earlier-than-expected approval for US pharma giant Merck & Co’s (NYSE: MRK) Keytruda (pembrolizumab)for use in previously untreated lung cancer patients, making it the only such drug so far cleared for first-line treatment.

Keytruda's latest approval is for treating first-line metastatic non-small cell lung cancer (NSCLC) in patients with high-levels of a protein called PD-L1, which makes them more receptive to immunotherapy.The FDA had previously set a target date for its decision on Keytruda in this new indication of December 24,

In addition, the FDA approved a labeling update to include data from KEYNOTE-010 in the second-line or greater treatment setting for patients with metastatic NSCLC whose tumors express PD-L1 (TPS of one percent or more) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy.