The Committee for Medicinal Products for Human Use decision is based on data from a pivotal Phase III trial, which showed that adding Avastin to interferon gave patients with advanced RCC the chance to live twice as long without their disease progressing (progression free survival) compared with interferon alone. It is the first recommendation by a regulatory authority for approval of Avastin for kidney cancer. It follows approvals of Avastin in colorectal (US, EU, Japan), breast (EU) and lung cancer (EU/US).
Bernard Escudier, head of Immunotherapy and Innovative Therapy Unit, Institute Gustave-Roussy, Paris, France and principal investigator of the pivotal study, said: “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.”