FDA accepted the New Drug Application for repotrectinib, a next-generation tyrosine kinase inhibitor, for the treatment of patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer based on results from the phase I/II TRIDENT-1 trial. FDA granted the application priority review and assigned a Prescription Drug User Fee Act goal date of November 27.
In his first sit-down interview since beginning his role as FDA commissioner 17 days earlier, Marty Makary, a former Johns Hopkins surgeon and the only Trump pick for HHS whose confirmation received Democratic support, said he would speed up approvals for rare-disease treatments by reducing reliance on animal testing and shifting towards organoids and computational models.
