Loxo Oncology Inc. said FDA has accepted the company’s New Drug Application and granted Priority Review for larotrectinib (LOXO-101) for adult and pediatric patients with locally advanced or metastatic solid tumors harboring an NTRK gene fusion.
The FDA has set a target action date of Nov. 26 under the Prescription Drug User Fee Act.
FDA grants Priority Review for the applications of medicines that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. Larotrectinib has also been granted Breakthrough Therapy Designation, Rare Pediatric Disease Designation and Orphan Drug Designation by the FDA.
Loxo Oncology and Bayer are in a collaboration for the development and commercialization of larotrectinib. Bayer plans to submit a Marketing Authorization Application in the European Union in 2018.
In an analysis of 55 RECIST-evaluable adult and pediatric patients with NTRK gene fusions, larotrectinib demonstrated a 75 percent centrally-assessed confirmed overall response rate and an 80 percent investigator-assessed confirmed ORR, across many different types of solid tumors. The majority of all adverse events were grade I or II.
Larotrectinib has been granted Priority Review, Breakthrough Therapy Designation, Rare Pediatric Disease Designation and Orphan Drug Designation.
In November 2017, Loxo Oncology and Bayer entered into an exclusive global collaboration for the development and commercialization of larotrectinib and LOXO-195, a next-generation TRK inhibitor.
Bayer and Loxo Oncology will jointly develop the two products, with Loxo Oncology leading the ongoing clinical studies as well as the filing in the U.S., and Bayer leading ex-U.S. regulatory activities and worldwide commercial activities. In the U.S., Loxo Oncology and Bayer will co-promote the products.
