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Last Updated: Thursday, 21 July, 2005, 08:43 GMT 09:43 UK
Breast cancer drug fast-tracked
Herceptin
The drug is already used for advanced cancer
The health secretary has ordered a fast-track assessment of a drug which has shown great promise in treating the early stages of breast cancer.

Patricia Hewitt intervened after concern Herceptin was being denied to patients who could benefit.

The National Institute for Health and Clinical Excellence (NICE) will now assess whether the drug should be made widely available on the NHS.

Herceptin is already used to treat women with advanced breast cancer.

It is specifically targeted at the one in four patients who have a form of the disease known as HER2 positive breast cancer.

I have the deepest sympathy for the pain and suffering that cancer patients and their families experience
Patricia Hewitt

But it is not yet licensed for treating breast cancer in its early stages.

However, preliminary tests have shown the drug is effective when given to these patients.

But more work needs to be done to be certain that the benefits of the treatment outweigh any potentially damaging side effects.

Ms Hewitt said she had asked NICE to start work on assessing the drug as soon as possible so it is in a position to act quickly if and when the drug receives a licence.

Application next year

The manufacturer, Roche, says it is likely to apply for a licence next year. A licence may granted within two or three months of the application.

Ms Hewitt said: "I have the deepest sympathy for the pain and suffering that cancer patients and their families experience and completely understand why they want to see any drug that can help made more widely available."

Mike Richards, National Cancer Director, welcomed the health secretary's decision.

He said: "Preliminary results on the use of Herceptin for early stage breast cancer are encouraging and it is important that the NHS receives timely advice on the clinical and cost effectiveness of these treatments."

John Melville, general manager of Roche UK, said: "We are doing everything within our power to gain a European marketing licence for early stage HER2 positive breast cancer patients as soon as possible, and we estimate a decision will be made by the European medicines regulatory agency (EMEA) between July and November 2006."

The charity CancerBACUP highlighted delays in patients accessing Herceptin in a report earlier this year.

Spokesperson Derryn Borley said: "Cancer patients who call our helpline want to know how soon they can get access to outstanding new treatments.

"It is important that the entire system of assessing cancer treatments is speeded up, from licensing to NICE guidance for use in the NHS."

Professor Alan Ashworth, of Breakthrough Breast Cancer, said: "Now that NICE have agreed to fast track the appraisal of Herceptin it's absolutely vital that it is licensed, and urgent consideration is given to enable access to standard testing for HER2 at diagnosis, if the potential benefits of this drug to save lives are to be realised quickly."

Insurance decision

BUPA, the major medical insurance company, announced this week that it would pay for patients with early stage breast cancer to use Herceptin.

Dr Natalie-Jane Macdonald, BUPA medical director, said: "Historically we have funded Herceptin as a treatment for late stage breast cancer in line with its current licence.

"However, given the impressive results of recent trials, we have decided to fund it for the treatment early stage breast cancer for HER2 positive patients because we believe it will directly benefit women with this diagnosis, and their families."

Mrs Hewitt has also asked NICE to fast track assessment of Velcade, a drug for the treatment of multiple myeloma.




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