The European Commission has approved bevacizumab (Avastin?, Roche) in combination with standard chemotherapy (carboplatin and paclitaxel) as a first-line treatment following surgery for women with advanced ovarian cancer.

Ovarian cancer is the eighth most commonly diagnosed cancer in women and the seventh leading cause of all cancer deaths among women worldwide. It is however, the most deadly of allgynaecological cancers, with approximately 220,000 women diagnosed and 140,000 women dying from the disease each year globally. [1] Surgery to remove as much of the tumor as possible, followed by chemotherapy, is a mainstay of treatment but unfortunately, the majority of patients are diagnosed with late stage disease when the cancer has grown or spread, and they require further treatment. The approval of bevacizumab marks a major advance in the treatment of women with ovarian cancer for whom treatment has been limited to surgery and chemotherapy.

First treatment advance in 15 years
?Today?s approval …marks the first major treatment advance in newly diagnosed ovarian cancer in 15 years,? said Hal Barron M.D., Chief Medical Officer and Head, Global Product Development. ?This is the fifth tumor type for which Avastin has been approved in Europe, making it one of few biologic drugs indicated for multiple cancers.”

Clinical studies
In two phase III studies (GOG 0218 and ICON7) bevacizumab has demonstrated that women with newly diagnosed advanced ovarian cancer who received the drug plus chemotherapy and then continued on the drug alone lived significantly longer without their disease getting worse (progression-free survival or PFS) compared to those who received chemotherapy only. Another trial (OCEANS in the recurrent, platinum-sensitive setting) also demonstrated a significant improvement in progression free survival.

Vascular endothelial growth factor
Ovarian cancer is associated with high concentrations of vascular endothelial growth factor (VEGF), a key driver of tumor angiogenesis ? a fundamental process required for a tumor metastasise. Bevacizumab is an antibody that specifically binds and blocks the biological effects of VEGF of which high levels are associated with ascites development (excess fluid in the body cavity), disease worsening, and a poorer prognosis in ovarian cancer patients.

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The drug’s precise mode of action allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments. As such it helps to control tumor growth and extend survival with only a limited impact on the side effects of chemotherapy.

The EU approval will enable 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 cancer.

[1] WHO, IARC GLOBOCAN, Cancer Incidence and Mortality Worldwidein 2008

For more information:
Bevacizumab Receives Broader EU labelfor Treatment of Women with Metastatic Breast Cancer;
Bevacizumab Receives Positive Opinion from Europe in Newly Diagnosed Advanced Ovarian Cancer.
Bevacizumab May Delay Progression in Newly Diagnosed Ovarian Cancer
– ASCO 2010: New Studies Report Stirring Progress Against Genitourinary, Gastrointestinal and Gynecologic Cancers

Clinical trials:
– Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal Cancer, or Fallopian Tube Cancer (GOC 0218)
– Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Newly Diagnosed Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer (ICON7)
– A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma (OCEANS)

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