FDA Avastin approved for Renal Cell cancer

The FDA recently approved Avastin for Renal Cell Cancer ....hope OvCa is next.

"FDA Approves Bevacizumab for Metastatic Renal Cell Carcinoma
OncologySTAT Editorial Team. 2009 Aug 4, B Bekiesz

The US Food and Drug Administration (FDA) has approved bevacizumab (Avastin), used in combination with interferon alfa-2a, for the treatment of metastatic renal cell carcinoma. Roche, the drug’s manufacturer, made the announcement on August 3.

The approval was based on results of the randomized, double-blind, placebo-controlled phase III AVOREN study, which showed a near-doubling of progression-free survival (PFS) in patients who received bevacizumab plus interferon compared with those who received interferon alone. Median PFS was 10.2 months for the bevacizumab/interferon alfa group vs 5.4 months for the interferon alfa–alone group. This represented an 89% improvement in median PFS. The 649 patients in the AVOREN study had received no prior treatment for their advanced renal cell carcinoma.

PFS, rather than overall survival (OS), was accepted by regulatory authorities in the United States and Europe as the endpoint for approval of bevacizumab for the renal cell carcinoma indication. No significant difference in OS between the treatment groups was noted. Median OS was 23 months in the bevacizumab/ interferon alfa group vs 21 months in the interferon alfa–alone group. A reduction in tumor size was observed in 30% of patients treated with bevacizumab plus interferon alfa compared with 12% of those treated with interferon alfa alone. Adverse events seen in this trial for bevacizumab and interferon alfa were consistent with those reported in previous trials.

The approval of bevacizumab for renal cell carcinoma adds a fifth FDA-approved indication for the drug, which is also approved for the treatment of breast, lung, and colon cancers and glioblastoma.

Bevacizumab blocks the action of the vascular endothelial growth factor (VEGF) receptor, a key factor in tumor angiogenesis, growth, and metastasis. Most renal cell carcinomas overexpress VEGF. Renal cell carcinoma accounts for 90% of cases of kidney cancer.

Bevacizumab is being studied in various tumor types at different stages. Combination therapy with everolimus, an mTOR inhibitor, is also being investigated. "