10 April 2025 - The full approval of Vitrakvi is based on the results of confirmatory trials that support Vitrakvi as a potential new standard of care treatment option for NTRK gene fusion-positive tumours in adult and paediatric patients.

Bayer today announced that the US FDA has granted full approval for Vitrakvi (larotrectinib), a first-in-class TRK inhibitor for the treatment of adult and paediatric patients with solid tumours that have a neurotrophic receptor tyrosine kinase 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.

Read Bayer press release