The Food and Drug Administration (FDA) granted Turning Point Therapeutics (TPTX +2.0%) a third Fast-Track designation to its lead drug candidate, repotrectinib for treatment of patients with advanced solid tumors that have an NTRK gene fusion.
Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
The drug was previously granted two Fast Track designations for the treatment of ROS1-positive advanced non-small cell lung cancer patients.
“We believe repotrectinib has the potential to make a meaningful difference in the lives of cancer patients with ROS1- or NTRK-driven tumors. NTRK-driven cancers are estimated to occur in up to 50K patients annually, however there are currently no approved therapies for those patients previously treated with another TRK TKI,” president & CEO Athena Countouriotis, M.D., commented.
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