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Last Updated: Friday, 17 February 2006, 10:38 GMT
Herceptin maker asks for licence
Ann Marie Rogers
Ann Marie Rogers lost her landmark legal challenge on Wednesday
The maker of breast cancer drug Herceptin has applied for a licence for it to be used to treat the early stages of the disease.

Manufacturer Roche claims its research shows the drug halves the risk of the HER-2 form of cancer returning.

On Wednesday, Ann Marie Rogers lost her landmark legal bid to get the drug on the NHS as it is not licensed for early-stage breast cancer.

The government promises that once it is, it will be fast-tracked in England.

It also said that guidance from the National Institute for Health and Clinical Excellence (NICE) on the drug would also be fast-tracked.

Leave to appeal

Mrs Rogers, a mother-of-three, has been given leave to appeal against the court's decision, and will be able to receive Herceptin treatment until then.

It targets the HER2 protein, which can fuel the growth of breast tumours
Herceptin prevents this process happening
Around a fifth of breast cancers are HER2 positive
It is currently licensed for use in women with advanced breast cancer - where the disease has spread within the breast or to another organ
Early stage breast cancer refers to the first occurrence of the disease
The cost for one year's treatment with Herceptin is £19,500

The judge ruled that Swindon Primary Care Trust, which had refused to fund the treatment, had not been acting unlawfully.

Mrs Rogers of Haydon Wick, Swindon, said if her breast cancer returns it would be a "death sentence".

Herceptin was licensed to treat secondary or late-stage breast cancer in March 2002, but recent research suggesting it may also benefit in the early stages prompted Roche's application to the European Medicines Agency.

Roche said that for treatment of early-stage HER2-positive breast cancer, Herceptin followed by chemotherapy "significantly reduces the risk of cancer coming back, by an outstanding 46%".

The HER-2 strain of the disease affects around 20 - 30% of women with breast cancer.

Roche spokesman Ed Holdener said: "We are very pleased to have been able to progress this application so rapidly, and commend the medical community and regulatory authorities worldwide for their close collaboration and continued support."

The NHS funding process for early stage treatment with Herceptin has been criticised as a "postcode lottery". Some health authorities have opted to pay for all eligible applicants and others have funded the drug's use only in "exceptional cases".

The lack of a license for its use in the early stages of breast cancer has created a postcode lottery
Breast Cancer Care

In Mrs Rogers' case, Swindon PCT adopted the latter policy, which follows current NHS guidelines.

Her lawyer Yogi Amin said it had been a "matter of public record" that Roche would apply for this early stage licence since late last year and the news was welcome.

"However this does not help the women who are currently living under a 'death sentence' from being denied this potentially life saving drug on account of where they live in England and Wales," he said.

Mr Amin, of law firm Irwin Mitchell, added they would continue to take Mrs Rogers' fight to the Court of Appeal.

Charity Breast Cancer Care welcomed the move.

Anna Wood, policy and campaigns manager said: "The lack of a license for its use in the early stages of breast cancer has created a postcode lottery, with people¿s access varying throughout the country.

"Today's submission of this license application is the start of the process to end the current inequalities that exist for patients trying to access the drug."

Last year, two woman, Barbara Clarke and Elaine Barber, threatened to take their primary care trusts to court, but both trusts backed down and agreed to supply the drug.

Health Secretary Patricia Hewitt has said health bosses must not use cost as an excuse not to fund the drug, and that decisions must be taken on a case by case basis.

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