EMA recommends approval of Vitrakvi (larotrectinib)

This is a summary of an article by the European Pharmaceutical Review.

Bayer AG's cancer treatment, Vitrakvi (larotrectinib), has been given a conditional approval by the human medicines committee (CHMP) under the European Medicines Agency (EMA).

In the European Union, Vitrakvi (larotrectinib) is the first cancer treatment set for approval which targets a specific gene in a solid tumour, regardless of its location in the body. This medicine is recommended for patients with Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion whose tumours have spread or cannot be removed with surgery, and who have no other suitable options.

Its conditional approval facilitates early access to medicines with less complete supporting data than normal in cases where the benefit of having the medicine outweighs the inherent risk.

Victoria Rees. EMA recommends Vitrakvi for EU marketing authorisation. European Pharmaceutical Review. 29/07/2019