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.
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