The approval was based on data from the pivotal Phase III Avoren trial, which showed that patients with advanced renal cell cancer (RCC) who received Avastin in combination with interferon (IFN) lived nearly twice as long without their disease progressing (progression free survival), as those who received IFN alone.
The Avoren study is a randomized, controlled, double-blind, Phase III study that included 649 patients with advanced kidney cancer from 101 study sites across 18 countries. Study participants received treatment with either Avastin and IFN alpha-2a or placebo and IFN alpha-2a, the standard of care in patients with advanced kidney cancer.
Bernard Escudier, principal investigator of the pivotal Avoren study, said: “Avastin effectively doubles the time in which patients live without their disease getting worse, so this approval has the potential to change the treatment landscape for this disease, where treatment options are still limited.”