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Merck KGaA's lung cancer therapy gets US FDA breakthrough status

Merck KGaA said the U.S. Food and Drug Administration granted breakthrough therapy status to its investigational lung cancer drug tepotinib.

The German pharmaceutical company is developing tepotinib to treat patients whose metastatic non-small cell lung cancer, or NSCLC, with the MET exon 14 skipping mutations worsened after receiving platinum-based cancer therapy.

Lung cancer is the most common type of cancer in the world, with 2 million cases diagnosed each year. Among 3% to 5% of NSCLC cases are positive with mutations in the MET signaling pathway, leading to aggressive tumor behavior and poor clinical diagnosis.

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Merck is evaluating tepotinib in an ongoing phase 2 study, dubbed Vision, to treat advanced NSCLC with MET exon 14 skipping mutations as detected by liquid or tissue biopsy.

In another mid-stage trial known as Insight 2, the company is investigating a combination of tepotinib and AstraZeneca PLC's Tagrisso in patients whose locally advanced or metastatic NSCLC is epidermal growth factor receptor mutation-positive and amplified by MET has acquired resistance to previous targeted therapy.