Bayer/Loxo drug approved in cancers with certain mutation

The FDA has approved Bayer and Loxo’s Vitravki (larotrectinib) for adults and children whose cancers have a specific genetic feature, or biomarker. This is only the second time the agency has approved a cancer treatment on the basis of its efficacy against a specific biomarker, rather than the location in the body in which a tumor originated. Vitrakvi is now approved for adult and pediatric patients with solid tumours that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation. Tumors must be metastatic or where surgical resection is likely to result in severe morbidity, and where no satisfactory alternatives are available.
The FDA said the approval marks a new paradigm in the development of cancer drugs that are “tissue agnostic”. The regulator has developed a guidance document for such drugs, which was released earlier this year. FDA Commissioner Scott Gottlieb said: “Today’s approval marks another step in an important shift toward treating cancers based on their tumor genetics rather than their site of origin in the body.”