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Study design: Pooled efficacy analysis based on 3 open-label, single-arm clinical studies in adult and pediatric patients with unresectable or metastatic solid tumors with an NTRK gene fusion. VITRAKVI is indicated for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase 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. This indication is approved under accelerated approval based on overall response rate and duration of response.

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Lead Sponsor. Loxo Oncology, Inc. Has Dmc.

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The first-in-class treatment option — developed by Bayer and Loxo Oncology, Inc. After approval for U. Overall, this type of cancer is rare, but can occur across a broad range of tumor types, including cancers of the salivary gland, thyroid, lung, colon, appendix, breast and pancreas.

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Larotrectinib, a small-molecule inhibitor of the TRK kinases, can be safely administered to adults with advanced solid tumorsaccording to results from a phase 1 study published online on January 8,in Annals of Oncology. In this phase 1 dose-escalation study, the primary end point was the safety of oral larotrectinib, including dose-limiting toxicity, and determination of maximum tolerated dose. Secondary end points included determination of pharmacokinetic parameters and antitumor activity.

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Sign in. Shashi WadhwaTapas C. MahapatraChitra Sarkar.

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Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. New data on patients with primary central nervous system CNS tumors of various histologies or brain metastases will be presented as part of an oral presentation. An analysis on quality of life QoL with Vitrakvi treatment was also conducted in both children and adults with TRK fusion cancer.

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Efficacy of larotrectinib in TRK fusion cancers. Nasdaq: LOXOa biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, today announced interim clinical data from all three ongoing larotrectinib LOXO clinical trials in patients whose tumors harbor tropomyosin receptor kinase TRK fusions. The larotrectinib pediatric data, included in this presentation, are also being presented in a separate oral presentation on Monday, June 5 th abstract

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