Loxo’s Vitrakavi granted accelerated approval by FDA

The U.S. Food and Drug Administration granted accelerated approval to Vitrakvi, or larotrectinib, a treatment for adult and pediatric patients whose cancers have a specific genetic feature. This is the second time the agency has approved a cancer treatment based on a common biomarker across different types of tumors rather than the location in the body where the tumor originated. The approval marks a new paradigm in the development of cancer drugs that are “tissue agnostic.” It follows the policies that the FDA developed in a guidance document released earlier this year. Vitrakvi is indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity and have no satisfactory alternative treatments or that have progressed following treatment. The FDA granted the approval of Vitrakvi to Loxo Oncology (LOXO). Reuters notes that the drug will be sold in partnership with Bayer (BAYRY).
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