EMA's Advisory Committee Backs Approval Of Incyte's Capmatinib In Advanced Lung Cancer Setting

The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommends granting marketing authorization for Incyte Corporation's 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 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.