Vitrakvi® (larotrectinib) – New orphan drug approval
November 26, 2018 - The FDA announced the approval of Loxo Oncology’s Vitrakvi (larotrectinib), for the treatment of adult and pediatric patients with solid tumors that: (1) have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, (2) are metastatic or where surgical resection is likely to result in severe morbidity, and (3) have no satisfactory alternative treatments or that have progressed following treatment.
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