Bayer announced that the European Commission has granted marketing authorization in the European Union (EU) for the precision oncology treatment Vitrakvi (larotrectinib). The drug is indicated for the treatment of adult and pediatric patients with solid tumors that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.
Facts about EU marketing authorisation of Vitrakvi
- Vitrakvi, a first-in-class oral TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, is the first treatment in the EU to receive a tumor-agnostic indication.
- Vitrakvi has demonstrated high response rates and durable responses in adults and children with TRK fusion cancer, including central nervous system (CNS) tumors.
- It is already approved in the US, Brazil and Canada.
- TRK fusion cancer is rare overall, affecting no more than a few thousand patients across Europe annually.
- Larotrectinib, an oral, highly selective TRK inhibitor, was investigated in clinical trials across 29 different histologies of solid tumors including lung, thyroid, melanoma, gastrointestinal stromal tumors, colon, soft tissue sarcomas, salivary gland and infantile fibrosarcoma.
- The compound has shown efficacy in primary CNS tumors as well as patients with brain metastases, across age or tumor histology.