CHMP nod for Roche's Avastin for ovarian cancer

June 28, 2014 | Saturday | Regulatory | By BioSpectrum Bureau

The new EU filing was based on results of the phase III AURELIA study

The new EU filing was based on results of the phase III AURELIA study

Singapore: EU Committee for Medicinal Products for Human Use (CHMP) has recommended European Commission to approve the use of Roche's Avastin (bevacizumab) in combination with chemotherapy as a treatment for women with ovarian cancer that is resistant to platinum-containing chemotherapy.

"Women with platinum-resistant ovarian cancer have limited medicines available for their difficult disease," said Ms Sandra Horning, chief medical officer and head, global product development. "EU approval of Avastin for platinum-resistant ovarian cancer would be an important step in helping these women live longer without their disease progressing, and we look forward to receiving the final decision from the European Commission in the coming months," she added.

The new EU filing was based on results of the phase III AURELIA study which involved women with recurrent, platinum-resistant ovarian cancer who received either chemotherapy or Avastin added to chemotherapy.

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