Herceptin gets European approval in record time

The breast cancer drug Herceptin has been approved in record time on the way to gaining a licence for use in early cases of the disease.

The revolutionary drug, which has been the subject of court battles between patients desperate to have it and NHS trusts reluctant to pay for it, was given the green light yesterday by a committee of the European Medicines Agency (EMEA).

The agency, which licences drugs in the UK and Europe, processed the application from Roche, the manufacturer, in 27 days compared with a normal time of three months. "It is the quickest it has ever happened," a source said.

Roche submitted its application on 17 February. The drug was approved for use in early breast cancer by the Committee for Human Medicinal Products at its monthly meeting this week. It will now go to a meeting of the full agency for ratification and the issuing of the licence, expected in 30 to 90 days.

Once licensed, it will be assessed by the National Institute for Clinical Excellence (Nice), which decides which drugs should be recommended for use on the NHS on the basis of their cost effectiveness. Herceptin costs £21,184 for a year's course for a woman with early breast cancer.

Nice began its appraisal process when the licence application was submitted on 17 February and has said it will fast track its decision, which is expected later in the summer.

The drug is already licensed for use in advanced breast cancer but its use in early breast cancer has become mired in controversy, after a series of court battles, the intervention of Patricia Hewitt, the Secretary of State for Health, and allegations that it has been over-hyped in a clever marketing campaign.

Studies published last year showed that Herceptin cut the risk of recurrence in women with early breast cancer by half - from 18 per cent to 9 per cent. But it only works in the 20 per cent of women with a particular genetic profile - sensitive to the protein Her2 - about 10,000 in the UK.

The normally sober New England Journal of Medicine described the results in an editorial as "simply stunning" and said they were "revolutionary, not evolutionary". No drug, not even Tamoxifen, the gold standard in breast cancer treatment for 30 years, had shown such a significant reduction in risk in so short a time (one to two-and-a-half years), it said. The journal said: "Our care of patients with Her2 positive breast cancer must change today."

Ms Hewitt took the hint and last October ordered NHS trusts not to withhold Herceptin on grounds of cost alone where a woman's doctor recommended it.

But some NHS trusts demurred after calculations showed that a 10 per cent reduction in the absolute risk of breast cancer returning (from 18 per cent to 9 per cent) translated into a cost of around £400,000 for each case of cancer prevented. Health economists argued the money could be better spent elsewhere.

The matter came to a head this month when Anne Marie Rogers won a legal battle for treatment with Herceptin in the Court of Appeal. Ms Rogers, 54, who is divorced and has three children, had been refused the drug by Swindon Primary Care Trust, a decision she described as a "death sentence." The Appeal Court held that as Swindon had claimed cost was not a consideration in its decision to withhold the drug, there was no rational basis to provide the treatment to one patient and not another.

Lawyers said the judgment still left it open to other trusts to ration the drug for women, provided they did so on a rational and consistent basis.