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FDA Approves TEPMETKO® as the First and Only Once-daily Oral MET Inhibitor for Patients with Metastatic NSCLC with METex14 Skipping Alterations


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ROCKLAND, Mass., Feb. 3, 2021 /PRNewswire/  EMD Serono, the healthcare business sector of Merck KGaA, Darmstadt, Germany in the US and Canada, today announced that the US Food and Drug Administration (FDA) has approved TEPMETKO
® (tepotinib) following Priority Review for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (
MET) exon 14 skipping alterations. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
The approval is based on results from the pivotal Phase II VISION study evaluating TEPMETKO as monotherapy in patients with advanced NSCLC with ....

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