Breakthrough cancer drug Avastin approved
pharmafile | January 20, 2005 | News story | Sales and Marketing |
Roche’s new colon cancer treatment Avastin has been approved by the European Commission, where it will go on sale at a 20% discount to its US price.
Avastin received approval as a first line treatment of patients with metastatic carcinoma of the colon or rectum in combination with two types of chemotherapy.
An anti-angiogenesis drug, Avastin is the first treatment of its kind with proven survival benefit for patients with advanced colorectal cancer to be approved and the first to treat patients with previously untreated metastatic colorectal cancer.
Professor Eric Van Cutsem, University Hospital Gasthuisberg, Leuven, Belgium, said: "Avastin represents the culmination of decades of research looking into the process of angiogenesis. It is the first drug that works by choking off the blood supply that feeds tumours."
European approval was based on data from a phase III study of Avastin plus the chemotherapy regimens of intravenous 5-fluorouracil/folinic acid or intravenous 5-fluorouracil/folinic acid/irinotecan.
The trial showed that patients treated with Avastin plus the chemotherapy regimens lived significantly longer than patients receiving the chemotherapy alone on average by nearly five months. Adding Avastin also limited the speed at which the disease progressed.
William Burns, chief executive of Roche Pharmaceuticals Division, said:"Today's full marketing approval represents a significant milestone for clinicians and patients across Europe engaged in the fight against cancer. We will now work to ensure that this breakthrough treatment is widely available throughout Europe as quickly as possible."
The product is predicted by Roche to reach peak sales of more than $2 billion a year. Avastin was co-developed by Genentech with Roche and then licensed to the latter to sell outside the US.
The companies are investigating the drug as a treatment in a number of other cancers, including non-small cell lung cancer, pancreatic cancer, breast cancer and renal cell carcinoma.
They expect to enrol around 15,000 patients in clinical trials worldwide. In 2000, colorectal cancer was the third most commonly reported cancer with 945,000 new cases worldwide; and over 50% of sufferers will die of the disease.
