Basel, 24 September 2010
Roche to provide EU regulatory update on Avastin in metastatic breast cancer
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that on behalf of the European Medicines Agency (EMA), the Committee for Medicinal Products for Human Use (CHMP) has started a review of Avastin® in combination with paclitaxel or docetaxel for the first-line treatment of metastatic breast cancer in view of data from the RIBBON-1 study. An application for a license extension based on the RIBBON-1 study is currently under review by the EMA. Roche is committed to working closely with the CHMP to make sure they have all the information they require for this review of Avastin in the first-line treatment of metastatic breast cancer.
Roches believes that based on a positive benefit/risk profile, the RIBBON-1 data support a label expansion of Avastin with Xeloda for the treatment of metastatic breast cancer in addition to the currently approved indication with paclitaxel or docetaxel. The CHMP opinion on this label expansion is expected later this year.
The current use of Avastin in its licensed indications including for the treatment of patients with metastatic breast cancer is not affected by this review. Roche believes that Avastin is an important first-line treatment option for women with metastatic breast cancer.
In Europe, Avastin has received full approval for the first-line treatment of patients with metastatic breast cancer in combination with paclitaxel (since 2007) or docetaxel (since 2009) based on the results of the phase III E2100 and AVADO studies, respectively. A positive benefit/risk profile of Avastin has been confirmed by the EMA in January 2010 in a renewal procedure for all approved indications. This procedure is conducted for all centrally authorized human medicinal products 5 years after granting initial marketing authorization.
About Avastin: Over 5 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 the US and Europe for the treatment of advanced stages of colorectal cancer, breast cancer, non-small cell lung cancer and kidney cancer, and Avastin is also available in the US and 23 other countries for the treatment of patients with glioblastoma (a type of brain 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 three quarters of a 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 tumor types (including colorectal, breast, non-small cell lung, brain, gastric, ovarian and others) and different settings (advanced or early stage disease).
About Avastin: Mode of Action
Avastin is an antibody that specifically binds and blocks the biological effects of VEGF (vascular endothelial growth factor). VEGF is the key driver of tumor angiogenesis – a fundamental process required for a tumor to grow and to spread (metastasise) to other parts of the body. Avastin’s precise mode of action allows it to be combined effectively with a broad range of chemotherapies and other anti-cancer treatments. Avastin helps to control tumor growth and extend survival with only a limited impact on the side effects of chemotherapy.
About an EU review procedure (referral)
Any Member State and/or the Commission can raise a concern regarding the manufacture, safety and/or efficacy of a medicinal product. The Commission requests CHMP’s opinion within a time-limit which it determines in the light of the urgency of the matter. Whenever practicable, the marketing authorisation holder shall be invited to provide oral or written explanations. Following an opinion by the CHMP, the Commission adopts the necessary provisional measures, which are applied immediately. The Commission adopts a final decision within six months. The CHMP makes the decision publicly accessible immediately after it has been taken.
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 personalised healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80’000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 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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1.Garcia M et al. Cancer Facts & Figures 2007. Atlanta, American Cancer Society, 2007