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.
FDA’s cancer czar Richard Pazdur had a “silver anniversary” at the agency recently. So, he invited some guests—the commissioners he had reported to under the Democratic and Republican administrations.
