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FDA Grants Tepotinib Breakthrough Designation for METex14-Altered NSCLC

Gina Columbus @ginacolumbusonc
Published: Wednesday, Sep 11, 2019

Luciano Rossetti, global head of Research & Development for the Biopharma business of Merck KGaA

Luciano Rossetti

The FDA has granted a breakthrough therapy designation to the investigational MET inhibitor tepotinib as a treatment for patients with metastatic non–small cell lung cancer (NSCLC) with MET exon14-skipping (METex14) alterations who have progressed on prior platinum-based chemotherapy.1

ex14 mutations by the Japanese Ministry of Health, Labor and Welfare.

References      

  1. Merck KGaA, Darmstadt, Germany, Announces FDA Breakthrough Therapy Designation for Investigational Therapy Tepotinib in Patients with Metastatic NSCLC with METex14 Skipping Alterations. Merck KGaA. Published September 11, 2019. https://prn.to/2kuDROO. Accessed September 11, 2019.        
  2. Pain PK, Veillon R, Cortot AB, et al. Phase II study of tepotinib in NSCLC patients with METex14 mutations. J Clin Oncol. 2019;37 (suppl; abstr 9005). doi: 10.1200/JCO.2019.37.15_suppl.9005.

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