Media Release

Basel, 31 October 2012

Roche medicine Avastin receives EU approval for the treatment of women with recurrent, platinum-sensitive ovarian cancer

Avastin is the first biological therapy approved for newly diagnosed and recurrent ovarian cancer

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today 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 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 Avastin 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.

“This EU approval of Avastin 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 the disease,” said 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 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<0.0001).

Ovarian cancer is associated with high concentrations of vascular endothelial growth factor (VEGF), a protein associated with tumour growth and spread. Avastin is an antibody that precisely targets and inhibits VEGF for tumour control.

About Ovarian Cancer

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 disease1. 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. 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.

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 in Ovarian Cancer: Research Programme

Roche has an extensive research and clinical trial programme investigating Avastin 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.

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.

This approval will enable the use of Avastin 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. Avastin is administered in combination with carboplatin and gemcitabine for 6 and up to 10 cycles, followed by continued use of Avastin as single agent until disease progression. The recommended dose of Avastin is 15 mg/kg of body weight given once every 3 weeks as an intravenous infusion.

About Avastin: Over 8 Years of 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, Avastin is continuing to transform cancer care through its proven survival benefit (overall survival and/or progression free survival) across several types of cancer. Avastin is approved in Europe for the treatment of 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. In addition, Avastin is approved in the US and over 30 other countries for the treatment of patients with glioblastoma (a type of brain cancer). Avastin is approved in Japan for the treatment of the advanced stages of colorectal, non-small cell lung cancer and breast cancer. Avastin 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.

Avastin has made anti-angiogenic therapy a fundamental pillar of cancer treatment today – over one million patients have been treated with Avastin so far. A comprehensive clinical programme with more than 500 ongoing clinical trials is investigating the use of Avastin in over 50 tumour types.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world’s largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche’s personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2011, Roche had over 80,000 employees worldwide and invested over 8 billion Swiss francs in R&D. The Group posted sales of 42.5 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com.

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