FDA Okays Avastin to Treat Aggressive and Late-Stage Cervical Cancer

The FDA panel gave a nod to Avastin - a drug to treat patients with persistent, recurrent or late-stage cervical cancer.

The National Cancer Institute estimates that nearly 12, 360 American women will be diagnosed with cervical cancer and nearly 4, 020 of them will die from the disease in 2014. The latest approval by the U.S. Food and Drug Administration offers hope to these patients.

Avastin, the first drug for patients of late-stage cervical cancer to be approved since 2006, plays a key role by mixing with the blood vessels that trigger the development of cancerous cells. The new drug is meant to be used along with chemotherapy drugs such as paclitaxel and cisplatin or in combination with paclitaxel and topotecan.

Cervical cancer grows in the tissue of the lower part of the uterus called cervix, it mostly occurs when the virus HPV (human papillomaviruses) spreads through sexual contact and causes the cells to become cancerous.

"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 new drug was reviewed for patients with cervical cancer under its priority review program. The safety and effectiveness of the drug to treat cervical cancer was tested in a clinical study that included 452 patients with persistent, recurrent or late-stage of the disease. The patients were randomly given either paclitaxel or cisplatin with or without Avastin, or paclitaxel and topotecan with or withour Avastin.

They noticed that there was increase in overall survival to 16.8 months in those who received chemotherapy along with Avastin when compared to 12.9 months for those receiving just chemotherapy.

The common side effects reported included fatigue, loss of appetite, hypertension, hyperglycemia, hypomagnesemia, urinary tract infection, headache and weight loss.

Avastin is marketed by South San Francisco, California-based Genentech, a member of the Roche Group.