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Merck KGaA: wins FDA breakthrough status for cancer drug

(CercleFinance.com) - The US FDA has granted breakthrough therapy designation to Merck's experimental drug as a treatment for an aggressive type of lung cancer, the German drugmaker said on Wednesday.


The Food and Drug Administration has granted breakthrough therapy designation for the targeted therapy tepotinib in patients with metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations who progressed following therapy.

Lung cancer is the most common type of cancer worldwide, with 2 million cases diagnosed annually.

Alterations of the MET signaling pathway are found in various cancer types, including 3-5% of cases, with poor clinical prognosis.

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