The United States Food and Drug Administration (FDA) approved a new use for the drug Avastin in patients recurring or late-stage cervical cancer.
Avastin interferes with the blood vessels that contribute to the development of cancerous cells, the FDA reported. It has been approved for use in combination with the chemotherapy drugs paclitaxel and cisplatin or paclitaxel and topotecan.
"Avastin is the first drug approved for patients with late-stage cervical cancer since the 2006 approval of topotecan with cisplatin," said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research. "It is also the first biologic agent approved for patients with late-stage cervical cancer and was approved in less than four months under the FDA's priority review program, demonstrating the agency's commitment to making promising therapies available to patients faster."
The drug's use was reviewed under the FDAs priority review program because the drug showed potential in improve the effectiveness and safety of common cervical cancer treatments. The drug's effectiveness was evaluated in a clinical study involving 452 participants who had persistent, recurrent, or late-stage disease. The study subjects were randomly assigned to take paclitaxel and cisplatin with or without Avastin or paclitaxel and topotecan with or without Avastin.
The results showed an increase in overall survival of 16.8 months is participants who received treatment in combination with Avastin compared to 12.9 months in those receiving chemotherapy alone. The most common side effects of the drug were "fatigue, decreased appetite, high blood pressure (hypertension), increased glucose in the blood (hyperglycemia), decreased magnesium in the blood (hypomagnesemia), urinary tract infection, headache and decreased weight. Perforations of the gastrointestinal tract and abnormal openings between the gastrointestinal tract and vagina (enterovaginal fistula) also were observed in Avastin-treated patients," the FDA reported.
