- The approval of Tabrecta in Japan follows U.S. FDA approval earlier this year
- Tabrecta is the third Incyte-discovered molecule to be approved by the MHLW
- Novartis has exclusive worldwide development and commercialization rights to Tabrecta
WILMINGTON, Del.--(BUSINESS WIRE)-- Incyte (NASDAQ:INCY) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved Tabrecta™ (capmatinib) for MET exon 14 skipping (METex14) mutation-positive advanced and/or recurrent unresectable non-small cell lung cancer (NSCLC). Tabrecta is approved for first-line and previously treated patients, regardless of prior treatment type.
Tabrecta is the third Incyte-discovered medicine to receive approval in Japan. Novartis has exclusive worldwide development and commercialization rights to Tabrecta. Approval of Tabrecta in Japan triggers a $20 million milestone payment to Incyte, and Incyte is also eligible to receive 12-14% royalties on global net sales of Tabrecta by Novartis.
“We are grateful for the efforts of Novartis Pharma K.K. and MHLW and are delighted that this important, targeted treatment option will now become available to patients in Japan diagnosed with METex14 NSCLC,” said Lothar Finke, M.D., Ph.D., Group Vice President, Head of Development and General Manager, Asia, Incyte. “This approval highlights the strength of the Incyte in-house discovery program, and our commitment to finding solutions for serious medical needs.”
The approval of Tabrecta is based on results from the pivotal GEOMETRY mono-1 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 v1.1. 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). The most common treatment-related adverse events (AEs) (incidence ≥20%) are peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.