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. The approval of this broad label is based on the results of two large international Phase III pivotal studies (NO16966 and E3200).
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 five 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. 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.
Alberto Sobrero, head of medical oncology, Hospital San Martino, Genoa, Italy, said: “This is a major turning point in the treatment of metastatic colorectal cancer patients. This approval means that many more patients can benefit from Avastin’s significant survival benefits.”