FDA Commissioner to Make Final Decision at a Later Date
BASEL, SWITZERLAND | June 30, 2011 | Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that, during a U.S. Food and Drug Administration (FDA) hearing on Wednesday, the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended that the FDA withdraw its approval of Avastin® (bevacizumab) in combination with paclitaxel chemotherapy for previously untreated (first-line) HER2-negative metastatic breast cancer. The committee’s recommendation is not the final decision and Avastin plus paclitaxel is still FDA approved for women with HER2-negative metastatic breast cancer. The FDA Commissioner will make the final decision on whether Avastin should remain approved for metastatic breast cancer. The FDA has not announced when the Commissioner will make the final decision.
“We are very disappointed by the committee’s recommendation and hope the Commissioner does not decide to remove this important medicine for women with an incurable disease who already have too few treatment options,” said Hal Barron, M.D., Chief Medical Officer and Head, Global Product Development. “We remain ready to collaborate with the FDA to find a solution that is in the best interest of patients who need Avastin.”
These proceedings and the ODAC’s recommendation have no impact on Avastin’s approved uses for other cancer types in the United States or the use of Avastin for metastatic breast cancer in other countries.
In Europe, Avastin is licensed in combination with paclitaxel chemotherapy and, as from yesterday, in combination with Xeloda (capecitabine) for women with metastatic breast cancer in the first-line setting. The EU Commission’s latest decision to extend the Avastin label provides an additional first-line treatment option for women in whom treatment with other chemotherapies (including taxanes or anthracyclines) is not considered appropriate.
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 over 32 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 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 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 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 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 2010, Roche had over 80’000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 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.
SOURCE: F. Hoffmann-La Roche Ltd
Post Views: 132
FDA Commissioner to Make Final Decision at a Later Date
BASEL, SWITZERLAND | June 30, 2011 | Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that, during a U.S. Food and Drug Administration (FDA) hearing on Wednesday, the FDA’s Oncologic Drugs Advisory Committee (ODAC) recommended that the FDA withdraw its approval of Avastin® (bevacizumab) in combination with paclitaxel chemotherapy for previously untreated (first-line) HER2-negative metastatic breast cancer. The committee’s recommendation is not the final decision and Avastin plus paclitaxel is still FDA approved for women with HER2-negative metastatic breast cancer. The FDA Commissioner will make the final decision on whether Avastin should remain approved for metastatic breast cancer. The FDA has not announced when the Commissioner will make the final decision.
“We are very disappointed by the committee’s recommendation and hope the Commissioner does not decide to remove this important medicine for women with an incurable disease who already have too few treatment options,” said Hal Barron, M.D., Chief Medical Officer and Head, Global Product Development. “We remain ready to collaborate with the FDA to find a solution that is in the best interest of patients who need Avastin.”
These proceedings and the ODAC’s recommendation have no impact on Avastin’s approved uses for other cancer types in the United States or the use of Avastin for metastatic breast cancer in other countries.
In Europe, Avastin is licensed in combination with paclitaxel chemotherapy and, as from yesterday, in combination with Xeloda (capecitabine) for women with metastatic breast cancer in the first-line setting. The EU Commission’s latest decision to extend the Avastin label provides an additional first-line treatment option for women in whom treatment with other chemotherapies (including taxanes or anthracyclines) is not considered appropriate.
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 over 32 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 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 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 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 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 2010, Roche had over 80’000 employees worldwide and invested over 9 billion Swiss francs in R&D. The Group posted sales of 47.5 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.
SOURCE: F. Hoffmann-La Roche Ltd
Post Views: 132
