EU approves Roche’s Avastin for platinum-resistant recurrent ovarian cancer

08-Aug-2014 - Switzerland

Roche announced that the European Commission (EU) approved the use of Avastin (bevacizumab) in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin chemotherapy as a treatment for women with recurrent ovarian cancer that is resistant to platinum-containing chemotherapy.

The EU approval 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 in combination with chemotherapy. Results showed that the addition of Avastin to chemotherapy gave a clinically meaningful benefit, nearly doubling the median progression free survival (PFS) from 3.4 months to 6.7 months (HR=0.38, p<0.0001).

“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,” said Sandra Horning, M.D., Roche’s Chief Medical Officer and Head, Global Product Development. “Avastin is the first biologic medicine approved by the EU for women with this difficult to treat disease.”

Ovarian cancer has the highest mortality rate of all gynaecological cancers. Of the 44,000 women diagnosed each year in the European Union many will have advanced disease that will return after initial treatment.When treating recurrent ovarian cancer, the time between receiving the last dose of platinum-based chemotherapy and disease recurrence is used to help determine the choice of chemotherapy used in the next line of treatment. Patients are said to have ‘platinum-resistant’ disease if their disease worsens between one and six months following completion of their platinum-based chemotherapy, and ‘platinum-sensitive’ disease if it worsens more than six months after. A quarter of those who relapse after initial treatment, over 10,000 women a year in the European Union, will have platinum-resistant cancer, the most difficult to treat form of the disease.

This approval will enable the use of Avastin in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin for the treatment of women with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than two prior chemotherapy regimens and who have not received prior therapy with Avastin or other VEGF inhibitors or VEGF receptor–targeted agents.

AURELIA is the fourth phase III study of Avastin in ovarian cancer to show that adding Avastin to chemotherapy significantly increased the time women with ovarian cancer lived without their disease worsening. In 2011, Avastin was approved in the EU as a front-line treatment for advanced ovarian cancer based on the pivotal GOG 0128 and ICON7 phase III studies. In 2012, Avastin was approved in the EU as a treatment for recurrent, platinum-sensitive ovarian cancer based on the results of the pivotal phase III OCEANS study.

https://www.bionity.com/en/news/149399/eu-approves-roches-avastin-for-platinum-resistant-recurrent-ovarian-cancer.html