After a review of the trial evidence — that took only ten weeks — a European Medicines Evaluation Agency (EMEA) committee has approved the drug for early-stage breast cancer. It was already licensed for patients at a later stage of the disease, when the cancer has spread.

Herceptin is not suitable for all cases of breast cancer but for those it can treat — up to a quarter of the total — it is more effective than existing treatments, reducing the likelihood of the cancer returning by 46 per cent.

A final hurdle, formal approval by the EU for marketing, remains before Herceptin gets its licence. That should take about six weeks.

Since the trial findings were published, campaigners have been pushing for rapid clearance of the medicine for early-stage disease. This month Ann Marie Rogers, a breast cancer patient, won a legal appeal to force her local health authority to pay for Herceptin, which costs about £20,000 a year.

EMEA said that Herceptin was the first drug to receive an “accelerated assessment” from its committee for human medicinal products.

The application for the new Herceptin use was submitted only in February this year and industry analysts said that the decision had come earlier than expected.

“The results from four large-scale trials speak for themselves: Herceptin consistently reduces the risk of relapse when used in early stages, providing the best chance of long-term survival to women with an extremely aggressive form of breast cancer,” said Ed Holdener, head of global pharmaceutical development for Roche, which makes the drug.

Since 1998, it has been used to treat more than 230,000 breast cancer patients worldwide, all with late-stage disease.

Jeremy Hughes, chief executive of Breakthrough Breast Cancer, said: “Breakthrough welcomes today’s news. Not only does this confirm the drug’s importance, it should also help to 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 [the National Institute for Health and Clinical Excellence], making the drug widely available across the NHS. We hope that in light of the decision, any primary care trust still wavering about prescribing Herceptin should now have the confidence to make it available to all for whom it is recommended.”

Nice is expected to issue its guidance in July. Andrew Dillon, chief executive of Nice, said yesterday: “We welcome the announcement from the first stage in the licensing process.

“We are assessing Herceptin through our new fast-track process. 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.”

The issue of a licence does not oblige primary care trusts to provide the drug, but a positive ruling from Nice would make it extremely difficult to refuse it to suitable patients.

• Nice issued final guidance yesterday that severely limits the use of two drugs for treating brain tumours. Gliadel has been ruled to be not cost-effective, while temozolomide can be used onlu in a limited number of cases.

  Neither drug provides a cure, but trial results show they can extend life.

  Robert Bradford, consultant neurosurgeon at the Royal Free Hospital in London, said “The decision by Nice is misguided and will deny patients the only treatment that clinicians have to treat aggressive tumour cells in the gap between surgery and subsequent radiotherapy or chemotherapy, a crucial period in treating brain tumours.”

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