Merck KgaA Granted FDA Approval for Lung-Cancer Drug Tepmetko

   By Cecilia Butini

Merck KgaA said late Wednesday that the U.S. Food and Drug Administration has granted approval to its lung-cancer drug Tepmetko following priority review.

The German pharmaceuticals and chemicals company said the drug was approved for the treatment of adult patients with metastatic non-small cell lung cancer who also present mesenchymal-epithelial transition exon 14 skipping alterations.

The approval was based on results from the phase-2 VISION study evaluating the drug as a monotherapy to treat such patients, the company said.

The European Medicines Agency validated a marketing authorization for the drug on a similar indication in November 2020, the company said, adding that applications were also submitted in Australia, Switzerland and Canada.

Write to Cecilia Butini at cecilia.butini@wsj.com

(END) Dow Jones Newswires

February 04, 2021 02:35 ET (07:35 GMT)

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