Stamford-based Loxo Oncology Inc. is moving forward the application process for a new drug that has promise as a cancer-fighting agent.
The company announced its completion of a rolling submission application to the U.S. Food and Drug Administration for larotrectinib – a tropomyosin receptor kinase (TRK) inhibitor – to be used in the treatment of patients with cancers that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion.
According to the company, research suggests that the NTRK genes, which encode for TRKs, can become abnormally fused to other genes, resulting in growth signals that can lead to cancer in many sites of the body. Larotrectinib has already been granted breakthrough therapy designation, rare pediatric disease designation and orphan drug designation by the FDA.
Last November, Loxo signed a global collaboration agreement with Bayer for the development and commercialization of larotrectinib and LOXO-195, a next-generation TRK inhibitor. A marketing authorization application submission by Bayer in the European Union is expected later this year.
“We are grateful to the many patients who participated in our clinical trials in the spirit of helping others with advanced cancer,” CEO of Loxo Oncology Josh Bilenker said. “We hope that the larotrectinib development program inspires others to develop drugs for both adult and pediatric patients on the basis of tumor genetics rather than tumor site of origin.”