Merck KGaA Gets FDA Breakthrough-Therapy Designation for Tepotinib
11 September 2019 - 8:49PM
Dow Jones News
By Colin Kellaher
Merck KGaA (MRK.XE) Wednesday said the U.S. Food and Drug
Administration granted breakthrough-therapy designation to its
tepotinib investigational therapy in a form of lung cancer.
The Darmstadt, Germany, science and technology company said the
designation covers tepotinib in patients with metastatic non-small
cell lung cancer harboring MET exon 14 skipping alterations who
progressed following platinum-based cancer therapy.
The FDA's breakthrough-therapy designation aims to expedite the
development and review of a drug for serious conditions when
preliminary clinical evidence shows the drug may show substantial
improvement over available therapies.
Lung cancer is one of the most common types of cancer worldwide.
Merck said alterations of the MET signaling pathway are found in 3%
to 5% of non-small cell lung cancer cases and correlate with
aggressive tumor behavior and poor clinical prognosis.
Write to Colin Kellaher at colin.kellaher@wsj.com
(END) Dow Jones Newswires
September 11, 2019 06:34 ET (10:34 GMT)
Copyright (c) 2019 Dow Jones & Company, Inc.
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