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NOVEMBER 28, 2018

FDA Approves Vitrakvi for Solid Tumors With NTRK Gene Fusions

By SPC News Staff

The FDA granted accelerated approval to larotrectinib (Vitrakvi, Loxo Oncology and Bayer) for adult and pediatric patients with certain solid tumors.

Larotrectinib is indicated for tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, which are either metastatic or where surgical resection is likely to result in severe morbidity. In addition, patients should have no satisfactory alternative treatments or a