Repotrectinib filed in Japan for ROS1-Positive NSCLC.- BMS
Bristol Myers Squibb said on October 25 that it has filed a new drug application for its ROS1 inhibitor repotrectinib for the treatment of ROS1-positive non-small cell lung cancer (NSCLC) in Japan.
The submission rides on the back of the results of the global PI/II study, called TRIDENT-1, which evaluated the safety and anti-tumor activity of repotrectinib in patients with advanced solid tumors including NSCLC that harbor ROS1, NTRK1-3, or ALK rearrangements.
The drug is an ATP-competitive small-molecule oral tyrosine kinase inhibitor (TKI) that selectively inhibits ROS1 and TRK A/B/C. It has already been filed for approval in the US for ROS1-positive NSCLC based on the same dataset, with the FDA target date set for November 27.
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