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European Commission approves Avastin for platinum resistant ovarian cancer
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The European Commission approved bevacizumab in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin chemotherapy as treatment for recurrent ovarian cancer in patients resistant to platinum-containing chemotherapy.
The commission based its decision on results from the randomized, open-label phase 3 AURELIA study, which included 361 patients with platinum-resistant ovarian cancer. Researchers assigned patients to chemotherapy plus bevacizumab (Avastin, Genentech) or chemotherapy alone. Patients completed questionnaires at baseline, and again after every two or three cycles of therapy.
Results showed the addition of bevacizumab to chemotherapy provided a clinically meaningful benefit, nearly doubling median PFS from 3.4 months to 6.7 months (HR=0.38, P<0.0001).
Sandra Horning
“European approval of Avastin for recurrent, platinum-resistant ovarian cancer is good news because Avastin can help women live longer without their cancer progressing, which is an important treatment goal in advanced disease,” Sandra Horning, MD, chief medical officer and head of global product development for Genentech, said in a press release. “Avastin is the first biologic medicine approved by the EU for women with this difficult to treat disease.”
The most common adverse events associated with bevacizumab were hypertension, gastrointestinal or genitourinary fistulas and thromboembolic events.