AVASTIN WITH INF APPROVED BY FDA FOR RENAL CANCER

August 4, 2009 — The US Food and Drug Administration (FDA) has approved a new indication for bevacizumab intravenous infusion (Avastin, Genentech, Inc) for the treatment of metastatic renal cell carcinoma. The recommended dose is 10 mg/kg every 2 weeks in combination with interferon α-2a (9 MIU subcutaneously 3 times weekly).

Bevacizumab is a monoclonal antibody that works by binding to vascular endothelial growth factor and preventing its role in angiogenesis, which deprives tumors of blood, oxygen, and other nutrients necessary to support their growth and metastasis.

"We hope that researchers someday find a cure for kidney cancer," said William P. Bro, chief executive officer of the Kidney Cancer Association in a company news release. "Until then, each new medicine...offers patients an opportunity to find a treatment best suited for them."

Approval of the indication was based on data from a global, randomized, double-blind, placebo-controlled phase 3 study — the Avastin in Renal (AVOREN) study — of 649 patients with newly diagnosed metastatic renal cell carcinoma, showing that the addition of bevacizumab to interferon α-2a significantly increased progression-free survival by 67% compared with interferon α-2a alone (10.2 months vs 5.4 months; hazard ratio [HR], 0.60; 95% confidence interval [CI], 0.49 – 0.72).

Results also showed that the combination therapy significantly decreased tumor size by 30% compared with 12% for interferon α-2a alone. However, no improvements were observed in median overall survival on the final analysis after 444 deaths (survival, 23 months vs 21 months; HR, 0.86; 95% CI, 0.72 – 1.04).

Adverse events reported in the study were consistent with the safety profiles for bevacizumab and interferon α-2a, with fatigue (13%), weakness (10%), proteinuria (7%), hypertension (6%), and bleeding (3%) most often reported.

Bevacizumab previously was approved for the treatment of metastatic colorectal cancer, nonsquamous non-small cell lung cancer, metastatic breast cancer, and glioblastoma.