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Roche's Avastin gets new EU nod in ovarian cancer

Wins new approval for hard-to-treat platinum-resistant recurrent form of disease

Roche Avastin bevacizumab cancer bottlesRoche's big-selling biologic Avastin has been approved in the European Union for the treatment of platinum-resistant, recurrent ovarian cancer, which affects 10,000 women a year.

It's a major new indication for the cancer drug and its Swiss manufacturer was keen to point out it makes Avastin the first new treatment option for women in Europe in more than 15 years for this difficult-to-treat form of the disease.

The European Commission says Avastin (bevacizumab) - global sales of which grew 8 per cent in 2013 to $6.7bn - can be used in combination with paclitaxel, topotecan or pegylated liposomal doxorubicin chemotherapy.

Approval was based on the phase III AURELIA study which found that when Avastin was added to chemotherapy it nearly doubled median progression free survival (PFS) from 3.4 months to 6.7 months compared with chemotherapy alone.

Median overall survival (OS) was 16.6 months versus 13.3 months and patients who received the combination had a higher rate of tumour shrinkage (28.2 per cent versus 12.5 per cent).

Roche's chief medical officer Sandra Horning said: “Avastin can help women live longer without their cancer progressing, which is an important treatment goal in advanced disease.”

Ovarian has the highest mortality rate of all gynaecological cancers, with many of the 44,000 women diagnosed each year in the EU having the advanced disease that will return after initial treatment.

The cancer is deemed platinum-resistant if the condition worsens between one and six months following completion of platinum-based chemotherapy - and this affects a quarter of the women who relapse after initial treatment.

The drug will be available to women who have had no more than two chemotherapy regimens beforehand and who have not received prior therapy with Avastin or other VEGF inhibitors or VEGF receptor–targeted agents.

Avastin is already approved in the EU for the recurrent, platinum-sensitive form of the disease - that is, when the disease gets worse more than six months after treatment, and was first given the green light in Europe for ovarian cancer in 2012.

Article by
Adam Hill

6th August 2014

From: Sales



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