FDA Approves Bevacizumab To Treat Advanced Renal Cell Carcinoma

As Reported by The Associated Press. 2009 Aug 2:

Avastin (bevacizumab) received approval from the Food and Drug Administration
(FDA) for a new indication to treat advanced renal cell carcinoma. This is the
most common form of kidney cancer. The FDA approval adds kidney cancer
indication to the 5 others for this drug, which include treatment of breast,
colon, and lung cancers. Bevacizumab, a targeted therapy for cancer, is an
angiogenesis inhibitor. Genentech, the manufacturer of Avastin, announced
approval for the new indication on August 2.

From Medscape, Aug 4:

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.

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.