EU approves Bayer’s Vitrakvi

Following approval from Brazil, Canada and latterly the US in 2018, the European Commission has now granted Bayer’s Vitrakvi (larotrectinib) conditional marketing authorisation in the EU for the treatment of adult and paediatric patients with solid tumours that display a neurotrophic tyrosine receptor kinase gene fusion, and is the first tumour-agnostic drug in Europe to be approved for the treatment of cancer. It is only indicated for patients whose cancer is locally advanced, metastatic, or where surgery is likely to result in death and so have no other viable treatment options.
Bayer’s medical director, Brendon Gray, said: “As the first tumour-agnostic medicine licensed in Europe, Vitrakvi represents a real shift in cancer treatment and creates an opportunity for the UK to demonstrate it is at the forefront of genomic medicine.”