Roche has moved a giant step closer to getting a fourth approval for Avastin after receiving a recommendation in Europe to market the drug as a treatment for advanced kidney cancer.

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Avastin (bevacizumab) for the first-line treatment of patients with renal cell carcinoma (RCC), the most common form of advanced kidney cancer. The recommendation is based on data from the Phase III AVOREN trial, which showed that adding Avastin to interferon gave patients with advanced RCC the chance to live twice as long without their disease progressing.

Specifically, AVOREN included 649 patients from 101 study sites across 18 countries who received treatment with either Avastin and interferon alpha-2a or placebo and interferon alpha-2a, a standard of care in advanced kidney cancer. Progression-free survival was almost doubled from a median of 5.4 to 10.2 months, while tumour response was significantly increased from 12.8% with interferon alone to 31.4% when Avastin was added. Roche also noted that the study also showed a trend towards improved overall survival.

The drug is already approved for colon, lung and breast cancers, so, as head of Roche’s pharmaceutical division, William Burns noted, “European doctors and clinics are already familiar with Avastin. We are therefore confident that we can bring [it] to patients with kidney cancer very quickly once it has been approved by the European authorities.” Bernard Escudier of the Institut Gustave-Roussy, Paris, and the principal investigator of AVOREN, said this drug “offers new therapeutic options in advanced kidney cancer, where chemotherapy and radiotherapy are not as effective as in other cancers”.

Avastin also shows promise in brain cancer
Meantime, Roche’s majority-owned partner Genentech has presented promising data from a mid-stage trial of Avastin in patients with the most aggressive form of brain cancer.

In a Phase II trial, Avastin, administered alone or with irinotecan chemotherapy, demonstrated an encouraging six-month survival rate for patients with glioblastoma multiforme. 36% of patients treated with Avastin alone and 51% on a combination of the drug and chemotherapy lived without the disease advancing within six months.

These findings exceeded our expectations, and due to the high unmet medical need of patients with relapsed GBM we plan to discuss these data with the FDA to determine next steps,” said Hal Barron, Genentech's chief medical officer. The data were presented at the 12th Annual Scientific Meeting of the Society for Neuro-Oncology in Dallas.