Basel, 27 May 2010
FDA advisory committee to review supplemental biologics license applications for Avastin for advanced breast cancer
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that the US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) will discuss the company’s two supplemental Biologics License Applications (sBLAs) for Avastin® (bevacizumab) for the treatment of women who have not received chemotherapy for advanced (metastatic) HER2-negative breast cancer during an advisory committee meeting on July 20, 2010.
These meetings are often used by the FDA to seek the advice and input of ODAC, an independent panel of experts, as part of the review process of products for the treatment of cancer. The FDA is expected to make a decision on the applications by September 17, 2010.
One sBLA is based on the Phase III study AVADO that investigated Avastin in combination with docetaxel chemotherapy. The other sBLA is based on the Phase III study RIBBON 1 that investigated Avastin in combination with a taxane-based, anthracycline-based or capecitabine chemotherapy.
Data from AVADO and RIBBON 1 are being submitted as part of this discussion to convert the accelerated approval in the US to a full approval. AVADO and RIBBON 1 both met their primary endpoints and showed that Avastin plus commonly used chemotherapies (taxane-based, anthracycline-based or capecitabine chemotherapy) increased the time women lived without the cancer growing or spreading (PFS), compared to the chemotherapies alone. In these studies, adverse events were consistent with those previously reported for Avastin and no new Avastin safety signals were observed.
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.
In Europe, Avastin is currently licensed for first-line treatment of patients with metastatic breast cancer in combination with paclitaxel or docetaxel based 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.
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
All trademarks used or mentioned in this release are protected by law.