Roche's Avastin cleared by EC

Swiss drug major Roche says that the European Commission has approved its Avastin (bevacizumab) for the treatment of colorectal cancer in combination with the chemotherapy regimens of intravenous 5-fluorouracil/folinic acid or intravenous 5-fluorouracil/folinic acid/irinotecan.

"Avastin represents the culmination of decades of research looking into the process of angiogenesis," noted Eric Van Cutsem of the University Hospital Gasthuisberg, Leuven, Belgium. "It is the first drug that works by choking off the blood supply that feeds tumors. Throughout several well-designed clinical trials, we have seen a meaningful increase in life expectancy when Avastin is combined with different chemotherapy regimens used in the treatment of advanced colorectal cancer," he added.

Approval was based on data from a landmark Phase III clinical trial study which demonstrated that patients treated with Avastin plus chemotherapy lived significantly longer than those receiving chemotherapy alone on average, nearly five months (20.3 versus 15.6 months). In addition, the agent increased the amount of time that patients were without disease progression, on average four months, compared to individuals receiving chemotherapy alone (10.6 vs 6.2 months), the firm said.