August 19, 2014 — FDA on Thursday approved Genentech's Avastin for the treatment of late-stage cervical cancer, in combination with chemotherapy drugs, the AP/New York Times reports (AP/New York Times, 8/15).
Avastin is the first drug approved for late-stage cervical cancer since 2006 and the first biologic agent approved to treat for disease, Richard Pazdur, FDA's director of hematology and oncology products, said.
FDA granted the new approval after reviewing results from a study involving 452 patients with late-stage, recurrent or persistent cervical cancer. The study found that participants who took Avastin in combination with paclitaxel and cisplatin or paclitaxel and topotecan had a median survival of 16.8 months, compared with 12.9 months among patients who used only paclitaxel and cisplatin or paclitaxel and topotecan (Bankhead, MedPage Today, 8/15).
FDA approved Avastin for use in combination with paclitaxel and cisplatin or paclitaxel and topotecan.
According to MedScape, Avastin was already approved to treat several other cancers, including forms of lung and colon cancer (Lowes, MedScape, 8/14). However, the agency in 2011 revoked its approval to treat advanced breast cancer after studies showed its benefits did not outweigh its risks (Women's Health Policy Report, 11/21/11).