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Last Updated: Friday, 28 April 2006, 09:41 GMT 10:41 UK
Herceptin given European backing
Ann Marie Rogers
Ann Marie Rogers won the legal right to receive Herceptin
The breast cancer drug Herceptin has been backed for use in early stages of the disease by European regulators.

The drug, the subject of legal battles, won the recommendation from a European Medicines Agency (EMEA) committee in a record 27 days.

A licence for the drug, useful in about a fifth of cases, is expected to be issued by the EMEA within 90 days.

The National Institute of Health and Clinical Excellence will then rule on whether to recommend it for NHS use.

Our approval of the drug is ongoing and we will issue guidance on it in July
Nice spokeswoman

NICE has already started looking at whether Herceptin, which costs around 20,000 a year, is a cost-effective use of taxpayers' money and is fast-tracking its appraisal process.

This began in February when manufacturers Roche submitted its application to the European authorities.

Andrew Dillon, NICE chief executive, said: "We will be able to issue national guidance to the NHS on the use of Herceptin within weeks of the drug being licensed for safety by the EMEA."

Herceptin is already licensed for use in advanced breast cancer cases.

But its use in early stage disease has been the subject of high profile battles by women seeking access to the drug by legal disputes, and concerns that its effectiveness is over-hyped.

Health Secretary Patricia Hewitt intervened in the debate last October to say NHS bodies should not withhold the drug on cost grounds from patients whose doctors had recommended it.

'Positive recommendation'

But some trusts still continue to refuse patients the drug pointing to research which suggested its benefits were not as great has had been thought.

Earlier this month Ann Marie Rogers of Swindon, Wiltshire, won an Appeal Court ruling forcing her local primary care trust to fund the treatment.

Although the ruling does not force all trusts to fund the drug, it did say it would be irrational to treat one patient with it and not another.

But lawyers argued the judgment still left the door open for primary care trusts to refuse to fund it if they provided a rational argument.

Herceptin targets the HER-2 protein, which can fuel the growth of breast tumours.

Around a fifth of breast cancers are HER-2 positive.

'Widely available'

In a statement, Roche said Herceptin had received "a positive recommendation" from the EU's committee for human medicinal products for the use of Herceptin following surgery and standard chemotherapy for early-stage HER2-positive breast cancer.

The news was welcomed by cancer charity Breakthrough Breast Cancer.

Chief executive Jeremy Hughes said: "Not only does this confirm the drug's importance, it should also help reassure those who may have previously doubted its effectiveness and safety.

"We look forward to Herceptin receiving its full licence soon, along with its fast appraisal by NICE, making the drug widely available across the NHS.

"We hope that in light of today's decision, any PCT still wavering about prescribing Herceptin, should now have the confidence to make it available to all for whom it is recommended."

Other drugs

The news comes as NICE said it was not willing to recommend two further breast cancer drugs, Docetaxel and Paclitaxel, for early stages of the disease.

There was too much uncertainty to make a clear judgement on Docetaxel's clinical and cost effectiveness compared with current practice in England and Wales, NICE said.

The institute has asked the drug's manufacturer to further clarify the evidence it make its final recommendations.

It has also decided not to recommend Paclitaxel for the treatment of early breast cancer following surgery, again because of the lack of evidence of its clinical and cost effectiveness.


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