Merck Drug Gets FDA Approval as a First-Line Lung Cancer Treatment

Merck & Co.'s immunotherapy cancer drug Keytruda received U.S. Food and Drug Administration approval as a first-line treatment for certain lung cancer patients.

The approval is for patients with metastatic non-small cell lung cancer whose tumors have high PD-L1 expression, with no EGFR or ALK genomic tumor aberrations.

The new indication means Keytruda can be an initial treatment instead of chemotherapy for these patients.

Additionally, the FDA approved a Keytruda labeling update for second-line treatment for certain patients, reflecting favorable data from the Keynote-010 trial.

Keytruda, or pembrolizumab, was first approved in 2014 for the treatment of melanoma. The Keytruda clinical development program includes more than 30 tumor types.

In October 2015, the drug was cleared for use as a second-line treatment for certain patients with non-small-cell lung cancer whose disease continued to worsen after the patient received chemotherapy or other drugs.

A Merck study published earlier this month showed that people who received Keytruda as their first treatment lived longer on average than those who received chemotherapy.

In a separate study of another immunotherapy drug, Bristol-Myers Squibb Co.'s Opdivo failed to significantly prolong survival beyond chemotherapy. Bristol-Myers tested Opdivo as a first-line treatment in a broader pool of lung cancer patients because the study also included those who had relatively low levels of PD-L1 in their tumors.

Write to Josh Beckerman at [e-mail]

(END) Dow Jones Newswires

October 24, 2016 21:25 ET (01:25 GMT)

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