FDA Approves Biologic Agent for Late-Stage Cervical Cancer

The FDA announced on Thursday the approval of a new treatment for cervical cancer developed by Genentech.

Bevacizumab (Avastin) is a treatment for patients with persistent, recurrent, or late-stage metastatic cervical cancer, which commonly occurs when human papillomaviruses cause cells to become cancerous. Bevacizumab treats 5 specific types of tumors by disrupting blood vessels that fuel developing cancer cells.

“Avastin is the first drug approved for patients with late-stage cervical cancer since the 2006 approval of topotecan with cisplatin,” said Richard Pazdur, MD, director of the Office of Hematology and Oncology Products for the FDA, in a press release. “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, demonstrating the agency’s commitment to making promising therapies available to patients faster.”

Bevacizumab was approved for use with chemotherapy drugs paclitaxel and cisplatin, or in combination with paclitaxel and topotecan.

In a study to assess the efficacy and safety of the drug, 452 women received paclitaxel and cisplatin with or without bevacizumab, or paclitaxel and topotecan with or without bevacizumab. Bevacizumab was found to improve overall survival with a 26% reduction in the risk of death for women who received bevacizumab with chemotherapy, compared to women who received chemotherapy alone.

The study showed an increase in overall survival of 16.8 months for patients who received chemotherapy in combination with bevacizumab, while those who received chemotherapy alone had an increase in survival of 12.9 months. Additionally, women who received bevacizumab with chemotherapy were found to have a significantly higher rate of tumor shrinkage.

Adverse events associated with bevacizumab in cervical cancer patients included fatigue, decreased appetite, hypertension, hyperglycemia, hypomagnesemia, urinary tract infection, headache, and weight loss. Researchers also noted perforations of the gastrointestinal tract along with abnormal openings between the gastrointestinal tract and vagina in the bevacizumab treatment group.

The researchers did not find an increase in treatment-related deaths in the bevacizumab with chemotherapy cohort compared with the chemotherapy alone cohort.

“With this approval, women with advanced cervical cancer now have the option of Avastin plus chemotherapy to help them live longer than with chemotherapy alone,” said Sandra Horning, MD, chief medical officer and head of Global Product Development for Genentech. “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.”