The company said that the CHMP has recommended doctors to prescribe Avastin to treat ovarian cancer in cases where the disease proves resistant to chemotherapies containing platinum.
Roche chief medical officer and head of Global Product Development Sandra Horning said women with platinum-resistant ovarian cancer have limited medicines available for their difficult disease.
"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," Horning said.
The new EU filing was based on data from the Phase III AURELIA trial, which included women with recurrent, platinum-resistant ovarian cancer who received either chemotherapy (weekly paclitaxel, topotecan or pegylated liposomal doxorubicin) or Avastin added to chemotherapy.
Results from the trial showed that at a median follow-up of 13 months for women who had received chemotherapy alone and 13.9 months for those who had received the combination, the addition of Avastin to chemotherapy gave a clinically meaningful benefit, nearly doubling the median PFS from 3.4 months to 6.7 months.
Currently, Avastin is approved in Europe to treat advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer and ovarian cancer.
The drug is available in the US for the treatment of colorectal cancer, non-small cell lung cancer and kidney cancer.
Image: EMA’s CHMP has recommended the use of Roche’s Avastin in combination with chemotherapy to treat women with a form of ovarian cancer. Photo: courtesy of Baitong333/ freedigitalphotos.net