Novartis has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) supporting European Union (EU) approval of Afinitor (everolimus) Tablets for the treatment of patients with advanced renal cell carcinoma (RCC).
The CHMP has recommended approval of Afinitor based on data demonstrating that when compared with placebo, Afinitor more than doubled the time without tumour growth or death in patients with advanced kidney cancer (4.9 vs. 1.9 months) whose disease progressed following prior therapy. Additionally, the data showed Afinitor reduced the risk of disease progression or death by 67 per cent (hazard ratio=0.33 with 95 per cent confidence interval 0.25 to 0.43; P<0.0001).
The European Commission generally follows the recommendations of the CHMP and delivers its final decision within two to three months. The decision will apply in all 27 EU member states. Regulatory reviews of Afinitor are underway in Switzerland, Japan and other countries.
"This positive opinion is good news for those living with advanced kidney cancer and puts us one step closer to offering these patients a new treatment choice that will fulfil an important unmet medical need," said David Epstein, president and CEO, Novartis Oncology, Novartis Molecular Diagnostics. "We also are studying the role of Afinitor for early kidney cancer, as well as its potential as a treatment for other tumour types."
In March 2009, the US Food and Drug Administration (FDA) approved Afinitor for use in patients with advanced RCC after failure of treatment with sunitinib or sorafenib, following a priority review of Afinitor based on its potential to fill an unmet medical need for these patients. Sunitinib and sorafenib are VEGF-targeted therapies, commonly used as initial treatments for advanced RCC.
Afinitor is approved in the US as the first oral, daily therapy (5 mg and 10 mg tablets) to treat patients with advanced RCC after failure of treatment with sunitinib or sorafenib.