Avastin receives positive opinion in Europe for advanced kidney cancer

The European Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for Roche's Avastin (bevacizumab) for the first-line treatment of patients with renal cell carcinoma (RCC).

The CHMP's decision is based on data from the pivotal phase III AVOREN trial, which showed that adding Avastin to interferon gave patients with advanced RCC twice the progression free survival time compared with interferon alone.

The AVOREN study is a randomised, controlled, double-blind phase III study that included 649 patients from 101 study sites across 18 countries. In the study patients received treatment with either Avastin and interferon ÃŽ±-2a or placebo and interferon ÃŽ±-2a, a standard of care in advanced kidney cancer.

The results showed that by adding Avastin to interferon progression-free survival was almost doubled from a median of 5.4 to 10.2 months; tumour response was significantly increased from 12.8% with interferon alone to 31.4% when Avastin was added; and dose-reduction of interferon did not appear to affect the efficacy of the combination of Avastin.

The study also showed a trend towards improved overall survival; however, the survival data are still pending. No new or unexpected adverse events were observed.

"The AVOREN study has shown us that Avastin is an effective and safe treatment for patients with kidney cancer," said Professor Bernard Escudier, head of immunotherapy and innovative therapy unit, Institut Gustave-Roussy, Paris, France and principal investigator of the pivotal AVOREN study. "This drug offers new therapeutic options in advanced kidney cancer, where chemotherapy and radiotherapy are not as effective as in other cancers."

Kidney cancer is the fourth cancer type in which Avastin has demonstrated survival benefits. Data from the comprehensive Avastin cancer clinical development programme have resulted in approvals in colorectal, breast, and lung cancer.