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Incyte Receives Approval For Tabrecta In Japan For Patients With Advanced NSCLC With METex14

Biopharmaceutical company Incyte Corp. (INCY) announced Monday 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. It is the third Incyte-discovered medicine to receive approval in Japan. Novartis AG (NVS) has exclusive worldwide development and commercialization rights to Tabrecta.

The approval of Tabrecta in Japan follows U.S. FDA approval earlier this year. The approval 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.

The approval of Tabrecta is based on results from the pivotal GEOMETRY mono-1 study. Tabrecta (capmatinib) is a kinase inhibitor that targets MET discovered by Incyte and licensed to Novartis in 2009.

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