Loxo Oncology has announced that it received approval from the U.S. Food and Drug Administration (FDA) for its cancer drug Vitrakvi, also known as larotrectinib.
According to the Stamford-headquartered company, Vitrakvi is the first oral tropomyosin receptor kinase (TRK) inhibitor that can be used in the treatment of patients with cancers that harbor a neurotrophic tyrosine receptor kinase (NTRK) gene fusion. The FDA previously granted Vitrakvi breakthrough therapy designation, rare pediatric disease designation and orphan drug designation, and the new approval enables Loxo Oncology and its development partner Bayer to sell the drug in oral capsules and as a liquid formulation for adults and children.
“We are grateful to the investigators, research teams and patients who contributed to and participated in the larotrectinib clinical trials that supported this approval,” said Josh Bilenker, CEO of Loxo Oncology. “The approval of Vitrakvi is a testament to the relentless prioritization of biology in the drug development process. It is now even more critical to screen patients of all ages with advanced solid tumors for actionable genomic insights that could benefit their care or aid in their referral to clinical trials.”