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FDA Approves Bevacizumab (Avastin) Plus Chemotherapy for Type of Ovarian Cancer

Treatment improves progression-free survival compared with chemotherapy alone

The FDA has given the nod to bevacizumab (Avastin, Roche) in combination with chemotherapy for the treatment of women with platinum-resistant, recurrent ovarian cancer.

The approval was based on results from the phase III AURELIA study, in which bevacizumab plus chemotherapy reduced the risk of disease worsening or death (i.e., progression-free survival [PFS]) by 62% compared with women who received chemotherapy alone (median PFS: 6.8 vs. 3.4 months, respectively; hazard ratio, 0.38; P < 0.0001).

Grade-3 or -4 adverse events occurring at a higher incidence in women receiving bevacizumab plus chemotherapy compared with women receiving chemotherapy alone included hypertension (6.7% vs. 1.1%, respectively) and hand-and-foot syndrome (4.5% vs. 1.7%).

The new indication is for the use of bevacizumab in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan chemotherapy for the treatment of women with platinum-resistant, recurrent, epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received no more than two prior chemotherapy regimens. With this approval, bevacizumab is approved in the U.S. to treat six distinct tumor types.

The AURELIA trial was a company-sponsored, randomized, open-label study in 361 women with platinum-resistant, recurrent, epithelial ovarian, primary peritoneal, or fallopian tube cancer who had received no more than two anticancer regimens prior to enrollment in the study. The participants were randomly assigned to one of six treatment arms (paclitaxel, topotecan, or liposomal doxorubicin with or without bevacizumab). The trial’s primary endpoint was investigator-assessed PFS.

An independent blood supply is critical for a tumor to grow beyond a certain size (2 mm) and to metastasize to other parts of the body. Tumors develop their own blood supply via angiogenesis by releasing vascular endothelial growth factor (VEGF) –– a key driver of tumor growth. Bevacizumab is an antibody that targets and inhibits VEGF. Targeted VEGF inhibition by bevacizumab allows the drug to be combined with a broad range of chemotherapies and other anticancer treatments.

Source: Roche; November 17, 2014.

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