Vitrakvi is approved for the treatment of 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. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
"Vitrakvi has a demonstrated clinical profile and is the only approved treatment specifically developed for patients with TRK fusion cancer," said Robert LaCaze, Member of the Executive Committee of the Pharmaceuticals Division and Head of the Oncology Strategic Business Unit at Bayer. "The U.S. FDA approval of FoundationOne CDx for Vitrakvi allows patients who may benefit from this treatment to be identified in a more precise way. We look forward to continuing our global collaboration with Foundation Medicine by expanding access to testing and determining the right treatment options for patients with cancer."
In the U.S., Vitrakvi (larotrectinib) is indicated for the treatment of adult and pediatric patients with solid tumors that have an NTRK gene fusion without a known acquired resistance mutation, are either metastatic or where surgical resection will likely 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
Vitrakvi is approved in 42 countries, including the U.S., Canada, Brazil and the European Union (EU). Additional filings in other regions are underway or planned.
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