Roche announced that the Swiss health authority Swissmedic has approved Avastin (bevacizumab, rhuMAb-VEGF) for the treatment of patients with previously untreated metastatic cancer of the colon or rectum. The Swiss approval lays the foundation for access to the medicine in more than 90 other countries. Roche will start to supply Avastin in Switzerland within the next few weeks and expects reimbursements to come through early next year.
Avastin is now approved for first-line treatment of patients with metastatic cancer of the colon or rectum in combination with the commonly used chemotherapy regimens of intravenous 5-fluorouracil/folinic acid or intravenous 5-fluorouracil/folinic acid/irinotecan.
"We were delighted when Swissmedic granted priority review to Avastin earlier this year, and now that the full marketing approval has been granted we will be working to ensure that Avastin is made available to cancer patients in Switzerland as quickly as possible," said William M. Burns, Head of Roche's Pharmaceuticals Division.
"The approval and availability of Avastin offers hope for patients with colorectal cancer, because it represents a major advance in the treatment of this disease. Avastin is the first drug that works by choking off the blood supply that feeds tumours," said Professor Richard Herrmann, Head of Oncology Department in the University Hospital Basel. "The significant increase in survival for patients provided by the addition of Avastin to a variety of different chemotherapy regimens used in the treatment of colorectal cancer, without the increase in side effects normally associated with chemotherapy, is a breakthrough in the treatment of this disease."
The approval is based on data from a landmark Phase III study published in the New England Journal of Medicine 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 worldwide2 and 3,700 in Switzerland3 respectively. It is estimated that over 50 per cent of people diagnosed with colorectal cancer will die of the disease.
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, renal cell carcinoma and others. 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).
Avastin was approved in February of this year in the US and has recently received full approval in Israel.