Download FDA Approves Avastin for Second-Line Treatment

FDA Approves Avastin for Second-Line Treatment of Metastatic
Published on Cancer Network (http://www.cancernetwork.com)
FDA Approves Avastin for Second-Line Treatment of Metastatic
Colon Ca
July 01, 2006 | Colorectal Cancer [1]
Avastin (bevacizumab, Genentech), in combination with FOLFOX4-oxaliplatin
(Eloxatin)/5-FU/leucovorin—has received FDA approval for the second-line treatment of metastatic
colorectal cancer.
ROCKVILLE, Maryland—Avastin (bevacizumab, Genentech), in combination with FOLFOX4-oxaliplatin
(Eloxatin)/5-FU/leucovorin—has received FDA approval for the second-line treatment of metastatic
colorectal cancer. The Avastin/FOLFOX4 combination was initially approved for the first-line
treatment of metastatic colorectal cancer in February 2004. Avastin is a recombinant, humanized,
monoclonal IgG1 antibody that binds to human vascular endothelial growth factor (VEGF) and
inhibits its biological activity, resulting in antiangiogenesis
E3200 Results
The drug's new indication is based on a randomized, controlled, multicenter phase III trial (E3200)
that enrolled 829 patients with advanced or metastatic colorectal cancer who had previously
received irinotecan (Camptosar) and 5-FU as their initial treatment for metastatic disease or as an
adjuvant therapy.
The open-label, three-arm, active-controlled trial randomized patients to receive Avastin alone,
Avastin plus FOLFOX4, or FOLFOX4 alone. Accrual to the Avastin-alone arm was closed after a
planned interim analysis found patients in that arm had a decreased survival, compared to those
receiving FOLFOX4 alone.
In the two arms with full accrual, the Avastin/FOLFOX4 group had a significant 25% reduction in the
risk of death, compared with the FOLFOX4-alone arm. This translated into a 33% improvement in
overall survival. The median survival for patients receiving the combination therapy was 13.0
months vs 10.8 months for the FOLFOX4-alone arm.
Source URL:
http://www.cancernetwork.com/articles/fda-approves-avastin-second-line-treatment-metastatic-colon
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Links:
[1] http://www.cancernetwork.com/colorectal-cancer
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