Bayer gets USFDA nod to FoundationOne CDx as Companion Diagnostic for larotrectinib
Whippany: Bayer has recently announced that the U.S. Food and Drug Administration (FDA) approved FoundationOne CDx for use as the first companion diagnostic to help identify neurotrophic receptor tyrosine kinase (NTRK) gene fusion-positive patients for whom treatment with Vitrakvi (larotrectinib) may be appropriate.
FoundationOne CDx is an FDA approved comprehensive genomic profiling (CGP) test for all solid tumors that incorporates multiple companion diagnostic indications, which will advance broader biomarker testing access for the cancer community.
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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