The drug received its UK licence for treatment of early-stage breast cancer yesterday. Many health trusts that had denied patients the drug argued that its safety remained unproven.

The move means that Herceptin will probably be approved by the National Institute for Health and Clinical Excellence (NICE), which recommends on best treatments for the NHS, within the next month. It is bringing forward an announcement, originally planned for July, as a result of the record speed with which the licence has been granted.

News of the licence, which is valid across the European Union and was granted by the European Commission on the advice of its regulator, was welcomed yesterday by patients.

Health trusts have said that the funding implications of the treatment, which costs about £20,000 a year a patient, will be significant and not easily resolved.

The drug is effective for the HER2-positive type of the disease, which affects about 20 to 25 per cent of women in whom breast cancer is newly diagnosed — a total of 10,000 patients annually.

Research published in The New England Journal of Medicine last October showed that Herceptin reduced the risk of disease returning in women with early-stage HER2-positive cancer by 46 per cent.

Breast cancer is diagnosed in more than 41,000 women every year, and more than 13,000 die each year.

Andrew Dillon, the chief executive of NICE, said that its appraisal of the clinical and cost-effectiveness of Herceptin was under way. “We are working hard to ensure our review is completed as soon as possible,” he said. “We are keen to ensure that guidance is available in a matter of weeks.”

Barbara Clark, 50, who won a High Court battle for Herceptin in October, described yesterday’s announcement as great news. “I feel this is the end of a tremendous fight,” she said.

Ms Clark, from Bridgwater, Somerset, faced having to sell her home to pay privately for the drug. She is now in remission. She said that once the drug was approved by NICE, health trusts will be forced to act. “Health trusts will then have three months to put their policies in place to give the drug and if they don’t, women will have a real fight on their hands,” she said. “(The trusts) won’t be able to refuse.”

Elisabeth Cooke, 60, from Southmead, Bristol, was absolutely delighted by the news. A High Court ruling in March put her case on hold but allowed her to continue receiving the drug pending her legal outcome. “Perhaps now all the scapegoating for all these women who need Herceptin will end,” she said.

Joanne Rule, the chief executive of the Cancerbackup charity, described yesterday’s decision as offering women a clear path to access a vital treatment. “Breast cancer patients across England and Wales are currently experiencing a dreadful postcode lottery — denied Herceptin because of where they live or how ‘exceptional’ their lives are deemed to be,” she said. “This can stop now.”

She added that the Department of Health should assist primary care trusts by announcing an innovation fund to help local areas to absorb the costs.

Professor Ian Smith, head of the breast unit at the Royal Marsden Hospital, southwest London, said that, for women with HER2-positive breast cancer, Herceptin was “one of the most important developments we have ever seen”.

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