Drug Cleared for Use in Treating Metastatic RCC
The FDA has approved Avastin (bevacizumab) plus interferon-alfa as a treatment for metastatic renal cell carcinoma (RCC).
Avastin blocks vascular endothelial growth factor (VEGF), a key underlying cause of cancer growth.This FDA approval is based on data from a global, randomized, double-blind, placebo-controlled Phase 3 study (AVOREN) of 649 patients with previously untreated metastatic RCC.
The trial showed that patients who received bevacizumab plus interferon-alfa had a 67% increase in progression-free survival (PFS) compared with subjects who received interferon-alfa alone.
In AVOREN, median PFS was 10.2 months for patients who received bevacizumab plus interferon-alfa compared with 5.4 months for patients who received interferon-alfa alone, which corresponded to an 89% improvement in median PFS. The combination-treatment arm showed no significant improvement in overall survival, however.