Loxo Oncology, Inc., a biopharmaceutical company developing selective medicines for patients with genetically defined cancers, today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application 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.
Research suggests that the NTRK genes, which encode for tropomyosin receptor kinases (TRKs), can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. In clinical trials, larotrectinib demonstrated anti-tumor activity in patients with tumors harboring NTRK gene fusions, regardless of patient age or tumor type.
“Larotrectinib marks an important shift towards treating cancer based on the tumor’s genetics rather than its site of origin in the body,” Josh Bilenker, M.D., chief executive officer of Loxo Oncology, said.
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, Rare Pediatric Disease Designation, and Orphan Drug Designation by the FDA.
Loxo Oncology and Bayer are engaged in a collaboration for the development and commercialization of larotrectinib. Bayer plans to submit a Marketing Authorization Application in the European Union in 2018.
(Source: Loxo Oncology, Inc.)
Filed Under: Drug Discovery
