Merck KgaA Granted FDA Approval for Lung-Cancer Drug Tepmetko
04 February 2021 - 6:50PM
Dow Jones News
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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