FDA accepts larotrectinib Bayer’s New Drug Application and grants priority reviewMay 29, 2018
The U.S. Food and Drug Administration (FDA) has accepted Bayer’s partner’s Loxo Oncology’s New Drug Application (NDA), and granted Priority Review for larotrectinib for the treatment of adult and pediatric patients with locally advanced or metastatic solid tumors harboring a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
The FDA has set a target action date of November 26, 2018, under the Prescription Drug User Fee Act (PDUFA).
NTRK gene fusions are genetic alterations that result in uncontrolled production of tropomyosin receptor kinase (TRK) fusion proteins, and lead to tumor growth. Bayer and Loxo Oncology are jointly developing larotrectinib, which is being studied globally for the treatment of patients across a wide range of cancers that harbor a NTRK gene fusion. Bayer plans to submit a Marketing Authorization Application (MAA) in the European Union in 2018.
“TRK fusion cancer is not limited to any organ or site of the body and occurs in both adults and children,” said Scott Fields, MD, senior vice president and head of Oncology Development at Bayer’s Pharmaceutical Division. “The Priority Review designation for larotrectinib may help bring this treatment option to patients, facing a high unmet medical need, as soon as possible.”
The 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, which is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and may demonstrate substantial improvement over available therapy on a clinically significant endpoint. Additionally, Rare Pediatric Disease Designation and Orphan Drug Designation were granted by the U.S. FDA.