Basel, 21 July 2010
Roche provides update from Avastin FDA advisory committee meeting
Genentech, Inc., a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced on 20 July that the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 12 to one that use of Avastin® (bevacizumab) in combination with paclitaxel for previously untreated (first-line) advanced HER2-negative breast cancer be removed from Avastin’s U.S. label. The committee’s vote does not affect the current availability of Avastin for people with advanced HER2-negative breast cancer in the United States. The FDA is expected to make a decision on the first-line use of Avastin in combination with certain types of chemotherapy in the United States for advanced breast cancer by September 17, 2010.
“We are disappointed by the committee’s recommendation and believe Avastin should continue to be an option for women with this incurable disease,” said Sandra Horning, M.D., senior vice president, global head, Clinical Development Hematology/Oncology. “We will continue to discuss the data from the more than 2,400 women who participated in three phase III studies with the FDA. This recommendation also does not impact Avastin’s approved uses for other cancer types.”
The recommendation also does not impact the use of Avastin for advanced breast cancer in other countries.
Avastin is currently approved in the United States in combination with paclitaxel chemotherapy for first-line treatment of advanced HER2-negative breast cancer. This approval was based on results of the phase III E2100 study and granted under the FDA’s accelerated approval program, which allows provisional approval of medicines for cancer or other life-threatening diseases. The effectiveness of Avastin in advanced breast cancer is based on an improvement in progression-free survival (PFS). Avastin is not approved for patients with breast cancer that has progressed following anthracycline and taxane chemotherapy administered for metastatic disease. Currently, there are no data available showing that Avastin improves disease-related symptoms or survival in HER2-negative advanced breast cancer.
In Europe, Avastin is currently licensed for the first-line treatment of patients with metastatic breast cancer in combination with paclitaxel or docetaxel 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.
In November 2009, the company submitted two supplemental Biologics License Applications (sBLAs) to the FDA based on the AVADO and RIBBON 1 studies as part of the company’s effort to convert the accelerated approval to a full approval.
The ODAC reviewed data from all three studies (E2100, AVADO and RIBBON 1), which showed that Avastin plus commonly used chemotherapies (taxane-based, anthracycline-based or capecitabine chemotherapy) increased the time women lived without the disease growing or spreading (PFS), compared to the chemotherapies alone. In these studies, adverse events were generally consistent with those previously reported for Avastin and no new safety signals were observed.
Avastin in Previously Untreated Advanced HER2-Negative Breast Cancer
Avastin has been evaluated in three separate international, multicenter, randomised phase III clinical studies of women who have not previously received treatment for advanced HER2-negative breast cancer:
- E2100: Avastin plus paclitaxel chemotherapy compared to paclitaxel chemotherapy alone (722 patients)
- AVADO: Avastin plus docetaxel chemotherapy compared to docetaxel chemotherapy alone (736 patients)
- RIBBON 1: Avastin plus either a taxane, anthracycline-based or capecitabine chemotherapy compared to the chemotherapies alone (622 patients in the taxane or anthracycline-based chemotherapies group, 615 patients in the capecitabine chemotherapy group)
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 24 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 tumour 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 tumour angiogenesis – a fundamental process required for a tumour 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 tumour 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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