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FDA approves Avastin for platinum-resistant, recurrent ovarian cancer
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The FDA today approved bevacizumab for use in combination with chemotherapy for the treatment of women with platinum-resistant, recurrent ovarian cancer, according to the drug’s manufacturer.
The expanded indication of bevacizumab (Avastin, Genentech) is intended for use in combination with paclitaxel, pegylated liposomal doxorubicin or topotecan chemotherapy for patients with platinum-resistant, recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer who have received no more than two prior chemotherapy regimens.
Sandra Horning
“Avastin plus chemotherapy is the first new treatment option for women with this difficult-to-treat type of ovarian cancer in more than 15 years,” Sandra Horning, MD, Genentech’s chief medical officer and head of global product development, said in a press release. “Risk of the disease worsening was reduced by 62% for women who received Avastin plus chemotherapy in the study, and a notable treatment effect was observed with paclitaxel, which may be important when choosing treatment.”
The approval was based in part on results from the phase 3 AURELIA study, designed to evaluate the safety and effectiveness of bevacizumab in 361 patients with histologically confirmed epithelial ovarian, fallopian tube or primary peritoneal cancer that progressed less than 6 months after the completion of platinum-based therapy.
PFS determined by RECIST served as the study’s primary endpoint. Objective response rate, OS, safety and patient-reported outcomes served as secondary endpoints.
According to study results, bevacizumab plus chemotherapy reduced PFS by 62% vs. women who received chemotherapy alone (median PFS, 6.8 months vs. 3.4 months; HR=0.38; P<.0001).
Patients treated with bevacizumab were more likely to develop grade 2 or higher hypertension and proteinuria. Gastrointestinal perforation was observed in up to 3.2% of bevacizumab-treated patients.