publication date: Aug. 30, 2014
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FDA Approves Avastin Combination For Late-Stage Cervical Cancer
FDA approved a new use for Avastin (bevacizumab) to treat patients with persistent, recurrent or late-stage cervical cancer. The new indication is approved for use in combination with 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,” said Richard Pazdur, 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.”
Avastin interferes with the blood vessels that fuel the development of cancerous cells. Avastin is also approved in the U.S. to treat cancers of the colon, kidney, and lung. The approval in advanced cervical cancer was based on the GOG-0240 study, which enrolled 452 participants with persistent, recurrent, or late-stage disease.
Participants were randomly assigned to receive paclitaxel and cisplatin with or without Avastin or paclitaxel and topotecan with or without Avastin. Results showed an increase in overall survival to 16.8 months in participants who received chemotherapy in combination with Avastin as compared to 12.9 months for those receiving chemotherapy alone.
GOG-0240 is an independent, NCI-sponsored study of the Gynecologic Oncology Group. Avastin is marketed by Genentech, a member of the Roche Group.
FDA approved Cologuard, the first stool-based colorectal screening test that detects the presence of red blood cells and DNA mutations that may indicate the presence of certain … Continue reading CCL August – FDA News
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