FDA approves MET inhibitor Tabrecta for metastatic non-small cell lung cancer with METex14 skipping mutation.- Novartis

Novartis announced that the FDA approved Tabrecta (capmatinib, formerly INC280), an oral MET inhibitor for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to MET exon 14 skipping (METex14) as detected by an FDA-approved test. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). This approval fills a long-recognized and urgent need among METex14 patients who have not had a treatment option approved to specifically target the driver of their lung cancer. Tabrecta is approved for first-line and previously treated patients, regardless of prior treatment type, and is expected to be available to patients in the coming days. The FDA also approved FoundationOneCDx as the companion diagnostic for Tabrecta, to aid in detecting mutations that lead to MET exon 14 skipping in tumor tissue. The approval of Tabrecta is based on results from the pivotal GEOMETRY mono-1 Phase II multi-center, non-randomized, open-label, multi-cohort study. In the METex14 population (n=97), the confirmed overall response rate was 68% (95% CI, 48-84) and 41% (95% CI, 29-53) among treatment-naive (n=28) and previously treated patients (n=69), respectively, based on the Blinded Independent Review Committee (BIRC) assessment per RECIST v1.11. In patients taking Tabrecta, the study also demonstrated a median duration of response of 12.6 months (95% CI, 5.5–25.3) in treatment-naive patients (19 responders) and 9.7 months (95% CI, 5.5-13.0) in previously treated patients (28 responders)1. The most common treatment-related adverse events (AEs) (incidence ?20%) are peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.