EU approves Roche’s Avastin in ovarian cancer
Roche is celebrating what it says is the first new treatment option in Europe for women with the most difficult-to-treat form of ovarian cancer in more than a decade.
The European Commission has approved Avastin (bevacizumab) with chemotherapy as a treatment for recurrent ovarian cancer which is resistant to platinum-containing chemotherapy.
More women die from ovarian cancer than from any other gynaecological cancer: 44,000 women are diagnosed each year in the EU, and more than 10,000 of those who relapse will have this type of the disease.
It is deemed 'platinum-resistant' if the cancer worsens between one and six months after treatment, while 'platinum-sensitive' refers to the disease getting worse more than six months after.
"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, Roche's chief medical officer.
"Avastin is the first biologic medicine approved by the EU for women with this difficult to treat disease," she added.
The vascular endothelial growth factor (VEGF) inhibitor can be used in combination with paclitaxel, topotecan, or pegylated liposomal doxorubicin chemotherapy for women with platinum-resistant recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer.
Patients must have received no more than two prior chemotherapy regimens and cannot have been treated with Avastin or other VEGF inhibitors or VEGF receptor–targeted agents before.
Approval was based on the Phase III AURELIA study, which showed that Avastin plus chemotherapy – as opposed to chemotherapy alone - nearly doubled median progression-free survival (PFS) in patients from 3.4 months to 6.7 months.
The drug was approved in the EU for recurrent, platinum-sensitive ovarian cancer - based on the results of another Phase III study, OCEANS – two years ago.
In 2011, it was given the green light by the EC as a front-line treatment for advanced ovarian cancer after positive results in the GOG 0128 and ICON7 Phase III trials.
Last month the US Food and Drug Administration granted Avastin priority review for the treatment of women with persistent, recurrent or metastatic cervical cancer.
Links
