FDA has granted Priority Review to capmatinib’s NDA to treat locally advanced or metastatic MET exon 14 skipping (METex14) mutated NSCLC.- Novartis
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Novartis announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion and recommended granting marketing authorization of Tabrecta (capmatinib) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
Tepotinib is recommended by NICE (National Institute for Health and Care Excellence- UK), within its marketing authorisation, in a final appraisal, as an option for treating advanced non-small-cell lung cancer (NSCLC) with METex14 skipping alterations in adults, only if the company provides tepotinib according to the commercial arrangement.
Merck KGaA announced that the European Commission (EC) has approved once-daily oral Tepmetko (tepotinib) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.