2 July 2020 - - The Japanese Ministry of Health, Labour and Welfare approved Tabrecta (capmatinib) for MET exon 14 skipping (METex14) mutation-positive advanced and/or recurrent unresectable non-small cell lung cancer (NSCLC), US-based Incyte (NASDAQ: INCY) said.

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 USD 20m milestone payment to Incyte, and Incyte is also eligible to receive 12-14% royalties on global net sales of Tabrecta by Novartis (NYSE: NVS).

The approval of Tabrecta is based on results from the pivotal GEOMETRY mono-1 study.

In the METex14 population, the confirmed overall response rate was 68% (95% CI, 48-84) and 41% (95% CI, 29-53) among treatment-naive and previously treated patients, respectively, based on the Blinded Independent Review Committee 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 (incidence ≥20%) are peripheral edema, nausea, fatigue, vomiting, dyspnea, and decreased appetite.

Tabrecta (capmatinib) is a kinase inhibitor that targets MET discovered by Incyte and licensed to Novartis in 2009. Under the terms of the agreement, Incyte granted Novartis exclusive worldwide development and commercialization rights to capmatinib and certain back-up compounds in all indications.

Incyte is eligible for a total of over USD 500m in milestones as well as royalties of between 12-14% on global net sales by Novartis.

Incyte is a Wilmington, Delaware-based, global biopharmaceutical company focused on finding solutions for serious unmet medical needs through the discovery, development and commercialization of proprietary therapeutics.