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FDA Actions & Updates

The latest approvals, designations, and new indications from the U.S. Food and Drug Administration for oncology drugs.

Friday, August 15, 2014
FDA Approves Avastin for Aggressive and Metastatic Cervical Cancers

The U.S. Food and Drug Administration has approved a new use for Avastin (bevacizumab) for the treatment of patients with persistent, recurrent, or metastatic cervical cancer. Avastin is a biologic antibody that binds to vascular endothelial growth factor (VEGF) to prevent tumor metastasis by inhibiting tumor blood supply. The new indication for cervical cancer is approved for use in combination with chemotherapy drugs paclitaxel and cisplatin, or in combination with paclitaxel and topotecan.

 

“Avastin is the first drug approved for patients with late-stage cervical cancer since the 2006 approval of topotecan with cisplatin,” Richard Pazdur, MD, Director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in a news release. “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.”

 

Avastin was granted Priority Review for this indication in cervical cancer in July. Avastin also has approved indications for the treatment of patients with metastatic colorectal cancer (OT 2/25/13 issue), and for the treatment of patients with first-line or previously untreated metastatic colorectal cancer (OT 3/25/04 issue).

  

The FDA’s priority review designation shortens the time to complete a drug’s review and aims to deliver a decision on marketing approval designation for drugs that may offer major advances in treatment or provide a treatment where no adequate therapy exists within six months under the Prescription Drug User Fee Act (PDUFA).

 

The safety and effectiveness of Avastin for this new approval for Avastin was evaluated in a clinical study of 452 patients with persistent, recurrent, or late-stage disease. Patients were randomly assigned to receive paclitaxel and cisplatin with or without Avastin, or paclitaxel and topotecan with or without Avastin. The results showed an increase in overall survival to be 16.8 months in patients who received chemotherapy and Avastin, compared with 12.9 months for patients receiving chemotherapy alone.

 

The most common side effects associated with the use of Avastin in patients with cervical cancer include fatigue, decreased appetite, hypertension, hyperglycemia, 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.

 

Avastin is marketed by Genentech.

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