The European Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for the use of Bevacizumab (Avastin, Genentech/Roche) in combination with standard chemotherapy (carboplatin and paclitaxel) as a front-line treatment for women with advanced ovarian cancer.

The positive CHMP opinion is an important milestone towards making bevacizumab available for a disease where few treatment advances have been seen in over a decade.

The most deadly gynaecological cancer
Ovarian cancer is the most deadly and most commonly diagnosed gynaecological cancers. It is the seventh leading cause of cancer death among women worldwide. Annually, over 220,000 women will be diagnosed with ovarian cancer around the world and approximately 140,000 will die from the disease.[1]

Treatment options
Surgery to remove as much of the tumour as possible is a mainstay of treatment but unfortunately, the majority of patients are diagnosed with late stage disease, when the cancer has grown or spread. In these cases, further treatment is required.

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Major development
In a setting with few advances in the last decade, bevacizumab has demonstrated in two phase III studies (GOG0218 and ICON7) that women who received the combination of bevacizumab and chemotherapy and then continued on bevacizumab alone, lived significantly longer without their disease getting worse (progression-free survival) compared to those who received chemotherapy only.

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?The positive CHMP opinion is great news for women with advanced ovarian cancer, who need more effective treatment options,? said Hal Barron M.D., Chief Medical Officer and Head, Global Product Development. ?Approval of Avastin would be a major development in this setting where few treatment advances have been seen in over a decade.?

Mode of Action
Bevacizumab is an antibody that specifically binds and blocks the biological effects of VEGF (vascular endothelial growth factor). VEGF is the key driver of tumour angiogenesis ? a fundamental process required for a tumour to grow and to spread (metastasise) to other parts of the body. Bevacizumab?s precise mode of action allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments. Bevacizumab helps to control tumour growth and extend survival with only a limited impact on the side effects of chemotherapy.

Protocol
The CHMP has supported the use of bevacizumab in combination with carboplatin and paclitaxel for the front-line treatment of advanced (FIGO stages IIIB, IIIC and IV) epithelial ovarian, primary peritoneal or fallopian tube carcinoma. Bevacizumab is administered for 6 cycles of treatment followed by continued use of Bevacizumab as single agent until disease progression or for a maximum of 15 months. The recommended dose of bevacizumab is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.

Transforming Cancer Care
With the initial approval in the USA for advanced colorectal cancer in 2004, bevacizumab became the first anti-angiogenic therapy made widely available for the treatment of patients with an advanced cancer.

Today, bevacizumab is continuing to transform cancer care through its proven survival benefit (overall survival and/or progression free survival) across several types of cancer. Bevacizumab is approved in the US and Europe for the treatment of advanced stages of colorectal cancer, breast cancer, non-small cell lung cancer and kidney cancer, and bevacizumab is also available in the US and over 32 other countries for the treatment of patients with glioblastoma (a type of brain cancer). Bevacizumab is the only anti-angiogenic therapy available for the treatment of these numerous advanced cancer types, which collectively cause over 2.5 million deaths each year.

Bevacizumab has made anti-angiogenic therapy a fundamental pillar of cancer treatment today ? over one million patients have been treated with bevacizumab so far. A comprehensive clinical programme with more than 500 ongoing clinical trials is investigating the use of bevacizumab in over 50 tumour types (including colorectal, breast, non-small cell lung, brain, gastric, ovarian and others) and different settings (advanced or early stage disease).

Final approval expected later this year.

For more information:
[1] WHO, IARC GLOBOCAN, Cancer Incidence and Mortality Worldwide in 2008

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