FDA approves Avastin for platinum-resistant, recurrent ovarian cancer

FDA approves Avastin for platinum-resistant, recurrent ovarian cancer

Roche has announced that the U.S. Food and Drug Administration (FDA) has approved Avastin (bevacizumab) for the treatment of patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer in combination with pacltiaxel, pegylated liposomal doxorubicin, or topotecan.

The drug is indicated for patients who have received no more than 2 prior chemotherapy regimens. The recommended dose of this indication is bevacizumab 10mg/kg every 2 weeks in combination with one of the above intravenous chemotherapy regimens, or bevacizumab 15mg/kg every 3 weeks in combination with topotecan.

The approval by the FDA is based upon the randomized, open-label, multicenter, phase 3 AURELIA trial, which investigated bevacizumab plus chemotherapy versus chemotherapy alone in 361 patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer that recurred within 6 months from the most recent treatment with platinum-based therapy.

Patients had a median age of 61 years. Median progression-free survival was 6.8 months and 3.4 months for chemotherapy plus bevacizumab and chemotherapy alone, respectively (P < 0.0001). Overall survival was 16.6 months and 13.3 months for chemotherapy plus bevacizumab and chemotherapy alone. This FDA approval is the sixth indication for Avastin.

Cancer drug Avastin is already enjoying wide acceptance in Europe after it was approved for use earlier in the year. The same could happen in the United States soon as the Food and Drug Administration recently approved the use of Avastin as a treatment option alongside chemotherapy in battling platinum-resistant, recurrent ovarian cancer. Roche announced the approval Monday, based on results from a Phase III AURELIA study showing that using Avastin in combination with chemotherapy cut risks of worsening or death by up to 62 percent in women who have platinum-resistant, recurrent ovarian cancer compared to those who underwent chemotherapy alone.

"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," said Roche Global Product Development Head and chief medical officer, Sandra Horning, M.D.