Larotrectinib FDA Submission Completed for TRK Fusion Cancer

March 26, 2018 – A rolling new drug application (NDA) has been completed for larotrectinib (LOXO-101) for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion. Loxo, which is codeveloping the pan-TRK inhibitor with Bayer, reported in December 2017 that the NDA had been initiated. The rolling submission followed a breakthrough therapy designation granted by the FDA in July 2016. Bayer … (leggi tutto)