Roche has announced that the European Commission has approved Avastin (bevacizumab, rhuMAb-VEGF), the new innovative anti-angiogenesis drug, for the treatment of patients with previously untreated metastatic colorectal cancer. Roche will now make Avastin available across Europe within the next few weeks and expects it to be accessible to physicians and patients early in the year.
Avastin is now approved for the first-line treatment of patients with metastatic carcinoma of the colon or rectum in combination with the chemotherapy regimens of intravenous 5-fluorouracil/folinic acid or intravenous 5-fluorouracil/folinic acid/irinotecan.
"Today's full marketing approval represents a significant milestone for clinicians and patients across Europe engaged in the fight against cancer," said William M. Burns, CEO of Roche's Pharmaceuticals Division. "We will now work to ensure that this breakthrough treatment is widely available throughout Europe as quickly as possible."
"Avastin represents the culmination of decades of research looking into the process of angiogenesis," said Professor Eric Van Cutsem, University Hospital Gasthuisberg, Leuven, Belgium. "It is the first drug that works by choking off the blood supply that feeds tumours. 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."
The European Commission's approval was based on data from a landmark Phase III study published in The New England Journal of Medicine in June 2004 that showed patients treated with Avastin plus chemotherapy lived significantly longer than patients receiving chemotherapy alone, on average by nearly five months (20.3 months versus 15.6 months).Also, the addition of Avastin increased the amount of time that patients were without disease progression, on average four months, compared to patients receiving chemotherapy alone (10.6 months versus 6.2 months).
In 2000, colorectal cancer was the third most commonly reported cancer with 945,000 new cases worldwide. It is estimated that over 50% of people diagnosed with colorectal cancer will die of the disease. In the European Union colorectal cancer is the second most common cause of death from any cancer in men.
Roche and Genentech are pursuing a comprehensive clinical programme investigating the use of Avastin in advanced colorectal cancer with other chemotherapies and also expanding into the adjuvant setting (post operation). As Avastin's mechanism may be relevant in a number of malignant tumours, Roche and Genentech are also investigating the potential clinical benefit of Avastin in other cancers, including non-small cell lung cancer, pancreatic cancer, breast cancer and renal cell carcinoma. Approximately 15,000 patients are expected to be enrolled into clinical trials over the next years worldwide.
Avastin is the first treatment that inhibits angiogenesis -- the growth of a network of blood vessels that supply nutrients and oxygen to cancerous tissues. Avastin targets a naturally occurring protein called VEGF (Vascular Endothelial Growth Factor), a key mediator of angiogenesis, thus choking off the blood supply that is essential for the growth of the tumour and its spread throughout the body (metastasis).