Chugai in new filing for entrectinib in Japan

18 March 2019

Roche majority-owned (ROG: SIX) Chugai (TYO: 4523) has filed a new drug application (NDA) to Japan’s Ministry of Health, Labor and Welfare for entrectinib for the treatment of ROS1 fusion-positive non-small cell lung cancer (NSCLC).

This follows a previous Japanese filing for the ROS1/TRK inhibitor in December 2018, on that occasion for NTRK fusion-positive locally advanced or metastatic solid tumors.

The latest application for approval is based on an integrated analysis of an open-label, multicenter, global Phase II study and three overseas Phase I trials. Efficacy was evaluated in 53 patients with ROS1 fusion-positive NSCLC while safety assessment was conducted with 355 patients registered in the four trials.

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