FDA Grants Complete Approval To Bayer's Drug For Certain Type Cancer With Mutation

The U.S. Food And Drug Administration (FDA) granted full approval to Bayer AG’s (OTC:BAYRY) Vitrakvi (larotrectinib) for adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion.

Vitrakvi has demonstrated clinically meaningful and durable responses across various NTRK fusion-positive solid tumors. FDA first granted Vitrakvi accelerated approval in November 2018.

The approval is ...