Avastin for the treatment of women with recurrent, Platinum-sensitive ovarian cancer: approved in Europe
Roche has announced that the European Commission ( EC ) has approved Avastin ( Bevacizumab ) in combination with standard chemotherapy ( Carboplatin and Gemcitabine ) as a treatment for women with first recurrence of Platinum-sensitive ovarian cancer.
Avastin is already approved in Europe as a front-line ( first-line following surgery ) treatment for women with advanced ovarian cancer.
This approval was based on data from the phase III OCEANS study which showed that women with recurrent, Platinum-sensitive ovarian cancer who received Avastin in combination with chemotherapy lived significantly longer without their disease getting worse ( progression-free survival ) compared to those who received chemotherapy alone ( HR=0.48; p less than 0.0001 ).
Ovarian cancer is the eighth most commonly diagnosed cancer in women and the seventh leading cause of cancer death among women worldwide. Each year, an estimated 230,000 women are diagnosed with ovarian cancer around the world, and approximately 140,000 die from the disease. 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 ) and they require further treatment.
Women are considered to have Platinum-resistant ovarian cancer if the disease comes back less than six months after completing prior Platinum-based chemotherapy.
Ovarian cancer is associated with high concentrations of vascular endothelial growth factor ( VEGF ), a protein associated with tumour growth and spread. Studies have shown a correlation between a high concentration of VEGF, disease worsening, and a poorer prognosis in women with ovarian cancer. Avastin is designed to specifically target VEGF.
Avastin has been shown to help women with ovarian cancer live longer without their disease getting worse in four large phase III clinical trials ( GOG 0218, ICON7, OCEANS and AURELIA ), and Avastin was approved for the treatment of women with newly diagnosed, advanced ovarian cancer ( front-line treatment ) in Europe in December 2011.
The new approval will enable the use of Bevacizumab in combination with Carboplatin and Gemcitabine for treatment of adult patients with first recurrence of Platinum-sensitive epithelial ovarian, fallopian tube or primary peritoneal cancer who have not received prior therapy with Bevacizumab or other VEGF inhibitors or VEGF receptor-targeted agents.
Bevacizumab is administered in combination with Carboplatin and Gemcitabine for 6 and up to 10 cycles, followed by continued use of Bevacizumab as single agent until disease progression.
The recommended dose of Bevacizumab is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.
Source: Roche, 2012