More patients with metastatic colorectal cancer are set to benefit from the broad label extension Avastin across Europe.
The European Commission (EC) gave Roche, based in Basel, Switzerland, 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 allow Avastin to be used in combination with any chemotherapy, including Roche's oral chemotherapy Xeloda (capecitabine), for first 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.
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 (1) 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.
"This news is highly significant for the estimated 400,000 (2) people diagnosed with metastatic colorectal cancer every year in Europe alone," said William M. Burns, member of the Executive Committee and ceo of the pharmaceuticals division at Roche. "This is another milestone in our commitment to developing effective and safe treatments for the large number of colorectal cancer patients throughout the world."
The approval of this broad label is based on the results of two large international phase III pivotal studies (NO16966 and E3200).
References
(1) Hurwitz H, Fehrenbacher L, Novotny W et al. Addition of bevacizumab (rhuMab-VEGF) to bolus IFL in the first-line treatment of patients with metastatic colorectal cancer: results of a randomized Phase III trial. New England Journal of Medicine 2004; 350(23): 2335-42.
(2) Ferlay J, AutierP et al. Estimates of the cancer incidence and mortality in Europe in 2006. Annals of Oncology 18: 581-592, 2007.