Roche Products (Ireland) Ltd., wish to announce that Avastin (bevacizumab) is approved in EU for the first-line treatment of patients with renal cell carcinoma, the most common form of advanced kidney cancer. Treatment options for patients with kidney cancer are limited. Surgical removal of part or the entire kidney forms the mainstay of treatment but is only really successful in early stage disease (cancer still confined to the kidney) where the 5 year survival rates are therefore relatively good at 60 to 75%. In later stage disease, however, treatment is more often employed with a view of controlling the cancer and improving associated symptoms and the 5 year survival rate is less than 5%. Unfortunately, because kidney cancer is often asymptomatic, the majority of patients are diagnosed at later disease stages. Avastin inhibits angiogenesis – the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin targets a naturally occurring protein called vascular endothelial growth factor (VEGF), a key mediator of angiogenesis, thus choking off the blood supply that is essential for the growth of the tumour and its metastasis. The new approval is based on data from the pivotal phase III AVOREN trial, assessing the benefits of adding Avastin to interferon alpha-2a, in patients with advanced renal cell carcinoma, compared with interferon alone (1). Study Design 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 alpha-2a or placebo and interferon alpha-2a. The primary endpoint was overall survival. Secondary endpoints included progression-free survival (survival without the disease progressing) and safety. Avastin offers patients the chance to live twice as long without their disease advancing The results of the AVOREN trial showed that by adding Avastin to interferon alpha-2a: *. 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% *. Dose-reduction of interferon did not appear to affect the efficacy of the combination of Avastin (based on PFS event free rates over time, as shown by a sub-group analysis) 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. An interim analysis of AVOREN was performed in December 2006 and the benefits provided by Avastin were so positive that the Drug Safety Monitoring Board (DSMB) recommended that the trial was unblinded and all patients were offered treatment with Avastin. Conclusion “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 announcement is very significant because this drug offers new therapeutic options in advanced kidney cancer, where chemotherapy and radiotherapy are not as effective as in other cancers.” Renal cell carcinoma is the fourth cancer type in which Avastin has demonstrated progression free survival benefits. In addition to renal cell cancer, data from the comprehensive Avastin cancer clinical development programme, the biggest ever clinical trial program in oncology, have resulted in approvals in metastatic colorectal, breast, and lung. Avastin is available in 100 mg and 400 mg vials. 1- Escudier B et al. Lancet. 2007 Dec 22;370(9605):2103-11. Full prescribing information and references available from Roche Products (Ireland) Ltd. Tel. 01-4690700