30-Jan-2008
Avastin receives broad label extension in Europe for the treatment of patients with metastatic colorectal cancer
Summary
-The European Commission has granted a broad label expansion for Avastin in combination with any standard chemotherapy in first and later treatment lines for patients with metastatic colorectal cancer. -This broad approval mean that virtually all patients currently suffering from colorectal cancer that has spread to other parts of the body will now have access to effective new treatments that have proven survival benefits. -The approval is based on the results of two large internationa
Last Updated: 27-Aug-2010
Roche announced today that the European Commission (EC) has given its approval for the significantly wider use of its anti-angiogenic agent Avastin (bevacizumab) in patients suffering from metastatic colorectal cancer.
This new broader label will now allow Avastin to be used in combination with any chemotherapy, including Roche’s oral chemotherapy Xeloda (capecitabine)*, for 1st and later treatment lines in patients with metastatic colorectal cancer. This news means that virtually all patients with metastatic colorectal cancer now have access to Avastin’s proven survival benefits. It is estimated that more than 400,000 people in Europe will be diagnosed with colorectal cancer in 2008.
The Avastin approval follows the European Committee for Medicinal Products for Human Use (CHMP) positive recommendations for the extended use of both Avastin and Xeloda in December 2007. *The final EC decision on Xeloda for its extended use is expected imminently.
The new Avastin label will allow it to be used in combination with every standard fluoropyrimidine based chemotherapy and also allows for combinations with Xeloda or oxaliplatin. Avastin formerly could only be used in combination with IV 5-FU or IV 5-FU/irinotecan-based chemotherapy regimen where it had demonstrated an impressive survival extension of nearly 5 months. Physicians now have the flexibility to use Avastin with a broad variety of standard chemotherapy of their choice in any line of metastatic colorectal cancer.
“This is a major turning point in the treatment of metastatic colorectal cancer patients," said Professor Alberto Sobrero, Head of Medical Oncology, Hospital San Martino, Genoa, Italy. “This approval means that many more patients can benefit from Avastin’s significant survival benefits.”
The approval of this broad label is based on the results of two large international phase III pivotal studies (NO16966 and E3200).
This new broader label will now allow Avastin to be used in combination with any chemotherapy, including Roche’s oral chemotherapy Xeloda (capecitabine)*, for 1st and later treatment lines in patients with metastatic colorectal cancer. This news means that virtually all patients with metastatic colorectal cancer now have access to Avastin’s proven survival benefits. It is estimated that more than 400,000 people in Europe will be diagnosed with colorectal cancer in 2008.
The Avastin approval follows the European Committee for Medicinal Products for Human Use (CHMP) positive recommendations for the extended use of both Avastin and Xeloda in December 2007. *The final EC decision on Xeloda for its extended use is expected imminently.
The new Avastin label will allow it to be used in combination with every standard fluoropyrimidine based chemotherapy and also allows for combinations with Xeloda or oxaliplatin. Avastin formerly could only be used in combination with IV 5-FU or IV 5-FU/irinotecan-based chemotherapy regimen where it had demonstrated an impressive survival extension of nearly 5 months. Physicians now have the flexibility to use Avastin with a broad variety of standard chemotherapy of their choice in any line of metastatic colorectal cancer.
“This is a major turning point in the treatment of metastatic colorectal cancer patients," said Professor Alberto Sobrero, Head of Medical Oncology, Hospital San Martino, Genoa, Italy. “This approval means that many more patients can benefit from Avastin’s significant survival benefits.”
The approval of this broad label is based on the results of two large international phase III pivotal studies (NO16966 and E3200).
