Posted by Michael Wonder on 29 May 2018
FDA accepts larotrectinib new drug application and grants priority review
29 May 2018 - PDUFA date set for 26 November 2018.
Loxo Oncology today announced that the U.S. FDA has accepted the company’s new drug application and granted priority review for larotrectinib for the treatment of adult and paediatric patients with locally advanced or metastatic solid tumours harbouring an NTRK gene fusion. The FDA has set a target action date of 26 November 2018, under the Prescription Drug User Fee Act.
Loxo Oncology and Bayer are engaged in a collaboration for the development and commercialisation of larotrectinib. Bayer plans to submit a marketing authorisation application in the European Union in 2018.
