The Food and Drug Administration has approved bevacizumab as a treatment for ovarian cancer, in combination with chemotherapy, based on the results of the AURELIA study, according to a Nov. 14 announcement by Genentech.
The approved indication is 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.
Bevacizumab, marketed as Avastin, a vascular endothelial growth factor–specific angiogenesis inhibitor, administered intravenously, is also approved for colon, lung, kidney, and cervical cancer indications. For the ovarian cancer indication, it is administered at a dose of 10 mg/kg IV every 2 weeks with paclitaxel, pegylated liposomal doxorubicin, or weekly topotecan; or 15 mg/kg IV every 3 weeks with topotecan given every 3 weeks, according to the updated prescribing information.
In the AURELIA study, a phase III open-label study, 361 women with platinum-resistant recurrent epithelial ovarian, primary peritoneal, or fallopian tube cancer and whom had been treated with more than two treatment regimens, were randomized to one of six treatment arms (paclitaxel, topotecan, or pegylated liposomal doxorubicin), with or without bevacizumab. In the intent-to-treat population, the primary endpoint, progression-free survival as assessed by the investigator, was 6.8 months among those on bevacizumab plus chemotherapy, compared with 3.4 months among those on chemotherapy alone, a highly statistically significant difference (hazard ratio, 0.38). Overall survival (a median of 16.6 months vs. 13.3 months) and overall response rates (28% vs. 13%) also favored those in the bevacizumab plus chemotherapy group.
Adverse events were consistent with those seen in studies of bevacizumab for the previously approved indications, “but also included high blood pressure and pain, redness or swelling of the hands or feet,” the company statement said. Grade 3-4 adverse events that affected at least 2% of women on bevacizumab were high blood pressure (6.7% among those on bevacizumab vs. 1.1% of those on chemotherapy alone) and hand-foot syndrome (4.5% vs. 1.7%) .
The bevacizumab label includes a boxed warning about the risk of gastrointestinal perforations, surgery and wound healing complications and hemorrhage associated with treatment.
Genentech, which sponsored the Aurelia study, is a member of the Roche group. The updated Avastin label is available at the FDA.
Serious adverse events associated with bevacizumab should be reported to the FDA’s MedWatch programonline or at 800-332-1088.