Posted by Michael Wonder on 24 Apr 2022
Novartis receives positive CHMP opinion for Tabrecta for patients with METex14 advanced non-small-cell lung cancer
22 April 2022 - Opinion 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 patients with advanced non-small cell lung cancer harbouring alterations leading to MET exon 14 (METex14) skipping.
Novartis announced today that the CHMP of the 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 harbouring alterations leading to mesenchymal-epithelial-transition factor gene (MET) exon 14 skipping who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.
