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Novartis receives approval from the European Commission for Tabrecta for the treatment of non-small cell lung cancer - News - PharmaTimes

Novartis receives European Commission approval for Tabrecta® for the treatment of METex14 skipping advanced non-small cell lung cancer

Incyte (Nasdaq:INCY) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency’s (EMA) has issued a positive opinion that recommends granting marketing authorization for capmatinib (Tabrecta®) as a monotherapy for the treatment of adults with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymalepithelial-transition factor gene (MET) exon 14 (METex14) skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

Press release content from Business Wire. The AP news staff was not involved in its creation.

The positive opinion from the CHMP is based on Phase 2 GEOMETRY mono-1 study showing an overall response rate (ORR) of 51.6% in a cohort evaluating second-line patients only and 44% in all previously-treated