Positive new analyses for Vitrakvi in adult and pediatric patients with TRK fusion cancer

German pharma major Bayer (BAYN: DE) yesterday announced positive findings from new analyses and data for Vitrakvi(larotrectinib), confirming the efficacy and safety of larotrectinib in patients with TRK fusion cancer.

The drug is approved for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic tropomyosin receptor kinase (NTRK) gene fusion without a known acquired resistance mutation that 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.5

This indication is approved under accelerated approval based on overall response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent on verification and description of clinical benefit in confirmatory trials, Bayer noted.