European Commission Approves Bevacizumab for the Treatment of Women with Recurrent, Platinum-sensitive Ovarian Cancer

The European Commission (EC) has approved bevacizumab (Avastin, Genentech/Roche)in combination with standard chemotherapy (carboplatin and gemcitabine) as a treatment for women with first recurrence of platinum-sensitive ovarian cancer.

Bevacizumab is already approved by the EC as a front-line (first-line following surgery) treatment for women with advanced ovarian cancer. The additional approval of the medicine is important for women with ovarian cancer who are now able to receive bevacizumab in combination with chemotherapy once their disease returns. Patients are said to have ‘platinum-sensitive’ disease if their ovarian cancer returns more than 6 months after completion of platinum-based chemotherapy.
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 [1]. 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.

Recurrent, Platinum-sensitive Ovarian Cancer
Patients are said to have ‘platinum-sensitive’ disease if their ovarian cancer returns more than six months after completion of the last platinum-based chemotherapy. Women are considered to have ‘platinum-resistant’ ovarian cancer if the disease comes back less than six months after completing prior platinum-based chemotherapy.

Vascular endothelial growth factor or VEGF
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. Bevacizumab is designed to specifically target VEGF.

Bevacizumab in Ovarian Cancer - Ongoing Research
Genentech and Roche have an extensive research and clinical trial programme investigating bevacizumab in patients with ovarian cancer in both the front-line and recurrent setting (when the cancer has returned after initial therapy), in order to help improve treatment outcomes for women with ovarian cancer. This ongoing research has shown that bevacizumab helps women with ovarian cancer live longer without their disease getting worse in four large phase III clinical trials (GOG 0218, ICON7, OCEANS and AURELIA). Based on the outcome of these studies, bevacizumab was approved for the treatment of women with newly diagnosed, advanced ovarian cancer (front-line treatment) in Europe.

The new European 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. In this treatment, 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.

Why important?
“This EU approval of bevacizumab is an important advance for women with recurrent ovarian cancer because very few treatment advances have been made in over a decade for patients with this disease,” explained Hal Barron M.D., Roche’s Chief Medical Officer and Head of Global Product Development.

This approval was based on data from the phase III OCEANS study which showed that women with recurrent, platinum-sensitive ovarian cancer who received bevacizumab 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<0.0001).

Transforming Cancer Care
With the initial approval in the USA for advanced colorectal cancer in 2004, Avastin 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, including advanced stages of breast cancer, colorectal cancer, non-small cell lung cancer, kidney cancer and ovarian cancer, and is available in the US for the treatment of colorectal cancer, non-small cell lung cancer and kidney cancer.

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.

References:
[1] WHO, IARC GLOBOCAN, Cancer Incidence and Mortality Worldwide in 2008

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Tags: Avastin, EC, Platinum-sensitive, Roche, bevacizumab, cancer, cell, lung, non-small, ovarian

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