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.
Credit: NCI/Linda BartlettIn an oral history conducted by FDA in September 2013, Andrew C. von Eschenbach recounted his eight-month stint in a dual role as both FDA acting commissioner and NCI director.
