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Published on 30 January 2008

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EC approves bevacizumab label extension

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The European Commission has approved the anti-angiogenic treatment bevacizumab (Avastin®) in combination with any standard chemotherapy at any stage of a patient’s treatment for advanced bowel cancer, according to manufacturer Roche.

The company says the broader indication could meet cost-effectiveness criteria for use in the UK’s NHS.

Dr Tim Iveson, a consultant oncologist at Southampton General Hospital, UK, commented: “Colorectal cancer is a devastating disease, and the second commonest cause of death from cancer in the UK.

“In recent years, treatment with chemotherapy and lately with biologic therapies has improved outcomes for patients.

“Until now, the indications for treatment with Avastin have been limited, but this new licence means that Avastin might be a treatment option for more patients with colorectal cancer.

“If treatment with bevacizumab, capecitabine and oxaliplatin was deemed to be a cost-effective treatment, more patients may be able to benefit from this treatment leading to improved survival, while maintaining good quality of life.”

Roche said the new label had already demonstrated survival extension of nearly five months in combination with an irinotecan-based chemotherapy regimen, and it would allow the beneficial combination of bevacizumab with standard fluoropyrimidine-based chemotherapy regimens, including combinations with capecitabine or oxaliplatin.

Physicians now had the option to use bevacizumab with a broad range of standard chemotherapy in metastatic colorectal cancer.

The broad bevacizumab indication approval is based on the results of the large international phase III pivotal studies NO16966 and E3200.

Roche



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