Novartis' Votubia cleared for non-cancerous kidney tumors in EU

Swiss drug major Novartis’ (NOVN: VX) shares rose 1.1% this morning, as the company revealed it has received approval from the European Commission for Votubia (everolimus) tablets for the treatment of adult patients with renal angiomyolipoma associated with tuberous sclerosis complex (TSC) who are at risk of complications (based on factors such as tumor size or presence of aneurysm, or presence of multiple or bilateral tumors) but who do not require immediate surgery. This marks the first approval of a medical treatment in this patient population in Europe.

The final European Union clearnance follows a recent positive recommendation from the European Medicines Agency’s advisory panel (The Pharma Letter September 24). Prior to this approval, surgical intervention was the only option in Europe for TSC patients.

Everolimus is approved as Afinitor in 90 countries including the USA and throughout the EU in the adult oncology settings of advanced renal cell carcinoma following progression on or after vascular endothelial growth factor (VEGF)-targeted therapy in the EU and after failure of treatment with sunitinib or sorafenib in the USA. Afinitor is approved for the treatment of locally advanced, metastatic or unresectable progressive neuroendocrine tumors of pancreatic origin in adults in the US and EU. Afinitor is also approved in the EU for the treatment of hormone receptor-positive (HR+), HER2/neu-negative (HER2-) advanced breast cancer.