EMA has recommended granting a conditional marketing authorisation in the European Union (EU) for Welireg (belzutifan) in adults with certain von Hippel-Lindau (VHL) disease-associated tumours and in adults with previously treated advanced kidney cancer (RCC).
VHL disease is a life-threatening rare genetic condition where people are more likely to develop non-cancerous or cancerous tumours, often in their eyes, brain, spine, kidneys, and pancreas. These growths may cause long-term debilitating symptoms like vision problems, headaches, or high blood pressure depending on their size and location. This disease, which affects approximately 3 in 100,000 people in the EU, is caused by a defect in a single gene, called the VHL gene, which is responsible for the production of a protein that prevents tumour formation…
