Avastin: First Molecule in Nearly a Decade for Metastatic Cervical Cancer

Avastin (bevacizumab), a monoclonal antibody that inhibits the vascular endothelial growth factor and prevents the growth of blood vessels (angiogenesis), has received FDA approval to treat patients with persistent or late-stage cervical cancer.¹ The approval allows administration of bevacizumab in combination with paclitaxel and cisplatin or paclitaxel and topotecan in the said population.²

The phase 3 study, conducted in 452 women, met its primary end point of improved overall survival (OS), with a significant 26% reduction in the risk of death when bevacizumab was combined with chemotherapy, compared with chemotherapy alone (median OS:16.8 months vs 12.9 months; hazard ratio = 0.74; P =.0132). Additionally, inclusion of bevacizumab resulted in a higher rate of tumor shrinkage compared with chemotherapy alone.²

Avastin, approved in 2004 as first-line treatment for patients with metastatic colorectal cancer, was the first angiogenesis inhibitor to be granted FDA authorization.³ Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said, “Avastin is the first drug approved for patients with late-stage cervical cancer since the 2006 approval of topotecan with cisplatin. It is also the first biologic agent approved for patients with late-stage cervical cancer and was approved in less than 4 months under the FDA’s priority review program.”¹

EBO

Some of the treatment-related side effects of Avastin include hypertension, thrombosis, and gastrointestinal-vaginal fistulas.² References

1. FDA approves Avastin to treat patients with aggressive and late-stage cervical cancer [press release]. Silver Spring, MD: FDA; August 14, 2014. http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm410121.htm.

2. FDA approves Genentech’s Avastin plus chemotherapy for treatment of advanced cervical cancer [press release]. South San Francisco, CA: Genentech; August 14, 2014.

http://www.gene.com/media/press-releases/14571/2014-08-14/fda-approves-genentechs-avastin-plus-che.

3. FDA approves first angiogenesis inhibitor to treat colorectal cancer [press release]. Silver Spring, MD: FDA; February 26, 2004. http:// www.fda.gov/newsevents/newsroom/pressannouncements/ 2004/ucm108252.htm.

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