NEW YORK – The European Commission on Wednesday approved Novartis' Tabrecta (capmatinib) for advanced non-small cell lung cancer (NSCLC) patients whose tumors harbor MET exon 14 skipping alterations.
The approval — which makes Tabrecta available for this biomarker-defined NSCLC patient population in Europe after prior treatment with immunotherapy and/or chemotherapy — follows a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use in April. It is based on the results of the Phase II GEOMETRY mono-1 clinical trial, in which the overall response rate among patients receiving second-line treatment was 51.6 percent. Among all previously treated NSCLC patients with METex14 skipping, the response rate was 44 percent.
In the US, Tabrecta has US Food and Drug Administration accelerated approval for metastatic NSCLC patients with mutations leading to METex14 skipping, regardless of patients' number of prior treatments. For that approval, the FDA approved Foundation Medicine's FoundationOne CDx next-generation sequencing test and subsequently its blood-based FoundationOne Liquid CDx test as companion diagnostics to determine METex14 skipping status.
In Japan, the agent is also approved for the same NSCLC patient population, regardless of prior lines of therapy.