- Tabrecta (capmatinib, formerly INC280) is the first and only therapy approved by the FDA to specifically target metastatic NSCLC with a mutation that leads to MET exon 14 skipping (METex14)1
- ~4,000-5,000 patients are diagnosed with METex14 metastatic NSCLC each year in the US and may face poor prognosis due to presence of the mutation2-3
- Tabrecta demonstrated an overall response rate of 68% and 41% in treatment-naive and previously treated METex14 patients, respectively1
- FDA approval reinforces the company’s bold vision to deliver innovative treatment approaches for patients living with lung cancer
Basel, May 6, 2020 - Novartis announced today that the US Food and Drug Administration (FDA) approved Tabrecta(TM) (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 cancer3. 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 FoundationOne CDx as the companion diagnostic for Tabrecta, to aid in detecting mutations that lead to MET exon 14 skipping in tumor tissue.
"Non-small cell lung cancer is a complex disease, with many different possible mutations that may encourage the cancer’s growth," said Juergen Wolf, MD, from the Center for Integrated Oncology, University Hospital Cologne and lead investigator of the GEOMETRY study. "MET exon 14 skipping is a known oncogenic driver. With today’s decision by the FDA, we can now test for and treat this challenging form of lung cancer with a targeted therapy, offering new hope for patients with NSCLC harboring this type of mutation."
Novartis was previously granted Breakthrough Therapy Designation for capmatinib. According to FDA guidelines, treatments that receive Breakthrough Therapy Designation must target a serious or life-threatening disease and demonstrate a substantial improvement over existing therapies on one or more significant preliminary research endpoints.
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