Posted by Michael Wonder on 26 Jul 2019
Bayer receives positive CHMP opinion for precision oncology treatment larotrectinib with first ever tumour-agnostic indication in in Europe
26 July 2019 - CHMP opinion is based on pooled data showing that larotrectinib provides high and durable responses in adult and paediatric patients with TRK fusion cancer, including CNS tumours.
The CHMP of the European Medicines Agency has recommended Bayer’s precision oncology treatment larotrectinib for marketing authorization in the European Union. The recommended indication is treatment of adult and paediatric patients with solid tumours 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.
Larotrectinib, a first-in-class oral TRK inhibitor specifically developed to treat tumors that have an NTRK gene fusion, will be the first treatment to receive a tumour-agnostic indication in the EU.
