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FDA has approved a new use for bevacizumab (Avastin, Genentech) in combination with chemotherapy for the treatment of patients with aggressive and late-stage cervical cancer.
FDA has approved a new use for bevacizumab (Avastin, Genentech) in combination with chemotherapy for the treatment of patients with aggressive and late-stage cervical cancer. The Agency approved Avastin in less than 4 months under its priority review program because the drug demonstrated the potential to be a significant improvement in safety and efficacy over available therapy.
Cervical cancer commonly occurs when human papillomavirus (HPV), a virus spread through sexual contact, causes human cells to become cancerous. The National Cancer Institute estimates that 12,360 American women will be diagnosed and 4,020 will die from cervical cancer in 2014.
“Cervical cancer is most commonly diagnosed in women between the ages of 35 and 44, and until today, chemotherapy was the only approved treatment option for women whose cancer recurred, persisted or spread,” said Sandra Horning, MD, chief medical officer and head of Global Product Development for Genentech.
Avastin is a monoclonal antibody that acts by binding to a protein called vascular endothelial growth factor (VEGF) and prevents the binding of VEGF to its receptors. This binding plays an important role in the lifecycle of the tumor to develop new blood vessels. By preventing the binding of VEGF to its receptors, Avastin interferes with the blood supply to the tumor which is critical to its ability to metastasize.
Avastin is available as a solution for intravenous injection. The new indication for cervical cancer is approved for use with chemotherapy drugs paclitaxel and cisplatin or paclitaxel and topotecan. With this new approval, Avastin is now FDA indicated for the treatment of 5 distinct tumor types including types of colon, lung, kidney and brain cancer.
In a study sponsored by the National Cancer Institute to assess the safety and efficacy of Avastin in combination with chemotherapy for the treatment of patients with late-stage cervical cancer, Avastin plus chemotherapy improved overall survival and significantly increased the rate of tumor shrinkage compared to chemotherapy alone.
The most common side effects associated with the use of Avastin in patients with cervical cancer include fatigue, decreased appetite, high blood pressure, increased blood glucose, urinary tract infection, headache and decreased weight. Patients may also experience slow wound healing, gastrointestinal perforation (a hole that develops in the stomach, small intestine or large intestine) and in some cases severe, potentially fatal bleeding. Avastin should be stopped at least 28 days prior to voluntary surgery due to slow wound healing and bleeding risk.
Erin Bastick is a PharmD Candidate 2016, Ohio Northern University, Ada, Ohio, and an inpatient intern at University Hospitals, Cleveland.