Roche: Chugai files application for anti-tumor drug in Japan
(CercleFinance.com) - Roche's Chugai said that it has filed for marketing approval of a treatment for extremely rare NTRK fusion-positive solid tumors with Japanese regulators.
The compound has already received an orphan drug designation from the Ministry of Health, Labour and Welfare (MHLW).
The drug's efficacy has been evaluated in 54 patients with untreated NTRK fusion-positive solid tumors while safety assessment has been conducted with 355 patients in four trials, Chugai said.
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