Agent approved to treat metastatic RCC

August 13, 2009

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.

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%).