FDA approves Loxo's larotrectinib, second tissue-agnostic approval from agency

FDA granted accelerated approval to Vitrakvi larotrectinib from Loxo Oncology Inc. (NASDAQ:LOXO), making the drug the second tissue-agnostic cancer treatment approved by FDA. Vitrakvi is a small molecule inhibitor of neurotrophic tyrosine kinase receptor 1 (TrkA; NTRK1), TrkB (NTRK2) and TrkC (NTRK3).

Vitrakvi is indicated to treat adult and pediatric patients with solid tumors that have an NTRK 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 therapy will be available immediately in capsule or oral liquid form...