Agent approved to treat metastatic RCC

Genentech, Inc. has earned FDA approval for bevacizumab (Avastin) plus interferon-alfa for treatment of metastatic renal cell carcinoma. Bevacizumab blocks the vascular endothelial growth factor (VEGF) protein responsible for tumor growth.

Approval was based on data from a global, randomized, double-blind, placebo-controlled, phase III study involving 649 patients with untreated metastatic renal cell carcinoma. Findings revealed that among those treated with bevacizumab plus interferon-alfa, there was a 67% increase in the length of progression-free survival compared with the survival rate in those who received interferon-alfa alone.

In this study, tumor size was reduced in 30% of patients receiving the combination therapy compared with 12% in those who received interferon-alfa alone.

Study-related adverse events for the patients taking the combination treatment versus placebo included fatigue (13% vs. 8%), weakness (10% vs. 7%), protein in the urine (7% vs. 0%), hypertension (6% vs. 1%), and bleeding (3% vs. 0.3%).