Press release
Incyte Announces FDA Approval of Tabrecta™ (capmatinib) for the Treatment of Patients with Metastatic Non-Small Cell Lung Cancer with METex14
- Tabrecta is the first and only U.S. Food and Drug Administration (FDA)-approved treatment for adult patients with metastatic non-small cell lung cancer
About this update from Incyte Corporation
[{"type":"text","content":"\n- Tabrecta is the first and only U.S. Food and Drug Administration (FDA)-approved treatment for adult patients with metastatic non-small cell lung cancer (NSCLC) with a mutation that leads to MET exon 14 skipping (METex14)\n\n\n- Tabrecta is the fourth molecule discovered by Incyte scientists to be approved by the FDA\n\n\n- Novartis has exclusive worldwide development and commercialization rights to Tabrecta\n\n WILMINGTON, Del.--(BUSINESS WIRE)--\nIncyte (Nasdaq:INCY) today announced that the U.S. Food and Drug Administration (FDA) has approved TabrectaTM (capmatinib) for treatment of 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). Tabrecta, the first and only treatment approved to specifically target NSCLC with this driver mutation, is approved for first-line and previously treated patients regardless of prior treatment type.\n\n\nNovartis has exclusive worldwide development and commercialization rights to Tabrecta, and the FDA approval of Tabrecta triggers $70 million in milestone payments from Novartis to Incyte. Incyte is also eligible to receive 12-14 % royalties on net sales of Tabrecta by Novartis.\n\n\nNSCLC accounts for approximately 85% of lung cancer diagnoses1. METex14 occurs in 3-4% of newly-diagnosed metastatic NSCLC cases2 and is a recognized oncogenic driver3,4.\n\n\n“We are pleased that the FDA has approved Tabrecta for patients with METex14 NSCLC,” said Steven Stein, M.D., Chief Medical Officer, Incyte. “Having a therapy that targets the recognized oncogenic driver will provide a much needed treatment option for patients with METex14 NSCLC who currently have limited treatment options. Tabrecta is the fourth Incyte molecule to be approved by the FDA, highlighting our world-class discovery program and commitment to bringing innovative medicines to patients in need.”\n\n\nThe approval of Tabrecta is based on results5 from the pivotal GEOMETRY mono-1 Study. In the METex14 population (n=97), the confirmed overall response rate was 68% (95% C...