- The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommends granting marketing authorization for Incyte Corporation's (NASDAQ:INCY) capmatinib (Tabrecta) for advanced non-small-cell lung cancer (NSCLC).
- The positive opinion covers capmatinib as a monotherapy for advanced NSCLC harboring alterations to mesenchymalepithelial-transition factor gene (MET) exon 14 (METex14) skipping those who require systemic therapy before treatment with immunotherapy and/or platinum-based chemotherapy.
- The CHMP opinion is based on data from the Phase 2 GEOMETRY mono-1 study that demonstrated positive overall response rates (ORR).
- In the 31 patients who received Tabrecta as second-line therapy in the METex14 skipping pretreated population, a confirmed ORR of 51.6% was achieved.
- The ORR across all 100 previously-treated patients, which included patients who received one or two prior lines of systemic therapy, was 44.0%.
- Novartis AG (NYSE:NVS) has exclusive worldwide development and commercialization rights to Tabrecta.
- Incyte is eligible for over $500 million in milestones and royalties of between 12-14% on global net sales by Novartis.
- Price Action: INCY shares are down 0.52% at $76.46 during the market session on the last check Friday.
