Merck KGaA, Darmstadt, Germany, Announces FDA Breakthrough Therapy Designation for Investigational Therapy Tepotinib in Patients with Metastatic NSCLC with METex14 Skipping Alterations

PRNewswire

Sep 11, 2019

- Investigational oral MET inhibitor has previously received SAKIGAKE 'fast-track' regulatory designation in Japan

- MET exon 14 skipping alterations and MET amplifications are present in 3-5% of non-small cell lung cancer patients and correlate with poor prognosis

- The designation is based on data from the ongoing VISION study, which showed preliminary clinical evidence for tepotinib in metastatic NSCLC harboring METex14 skipping alterations

PR Newswire

DARMSTADT, Germany, Sept. 11, 2019

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