Basel, 18 September 2010
Roche provides update on Avastin for advanced breast cancer in the U.S.
FDA Extends Review Period for Supplemental Biologics License Applications
Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that information submitted by the company to the U.S. Food and Drug Administration (FDA) during the review of the supplemental Biologics License Applications (sBLAs) for Avastin (bevacizumab) for previously untreated (first-line) advanced HER2-negative breast cancer has been deemed a major amendment. In accordance with FDA guidelines, the agency has extended the review period for the sBLAs by an additional 90 days. The company now anticipates FDA action on the sBLAs by December 17, 2010.
At this time, Avastin remains under accelerated approval in combination with paclitaxel for the first-line treatment of HER2-negative metastatic breast cancer. The FDA is currently reviewing two sBLAs that Genentech submitted in November 2009 for Avastin in combination with taxane-based, anthracycline-based and Xeloda (capecitabine) chemotherapies based on the results of the AVADO and RIBBON1 studies. Data from AVADO and RIBBON1 were submitted as part of Genentech’s effort to convert the accelerated approval to a full approval.
“We are pleased by the FDA’s decision to review additional information on Avastin and are committed to working closely with the agency during this extended review period,” said Hal Barron, Head Global Development and Chief Medical Officer at Roche.
Today’s announcement does not impact Avastin’s availability for its approved uses for other cancer types in the U.S. or approved uses, including breast cancer, in other countries.
In February 2008, FDA granted accelerated approval for Avastin in combination with paclitaxel chemotherapy for first-line treatment of advanced HER2-negative breast cancer. The approval was based on an improvement in progression-free survival (PFS).
In Europe, Avastin is licensed for the first-line treatment of patients with advanced breast cancer in combination with paclitaxel (since 2007) or docetaxel (since 2009) based on the results of the phase III E2100 and AVADO studies. An application for a license extension based on the RIBBON 1 study is currently under review by European regulatory authorities.
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 advanced brain cancer (glioblastoma). 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.
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