In an unprecedented move, the UK’s Secretary of State for Health, Patricia Hewitt, has ordered that, from this week onwards, women diagnosed with early-stage breast cancer will be tested for suitability to receive treatment with Swiss drugmaker Roche’s Herceptin (trastuzumab).

This will allow women to gain access to the drug as soon as its licence is extended to include treatment of early-stage breast cancer; a submission to the European Medicines Agency requesting clearance for this is expected by February 2006. If granted, Herceptin will be fast-tracked for use throughout the National Health Service.

According to Department of Health estimates, the use of Herceptin in the early-stage setting could save around 1,000 lives a year, at an annual cost of about £100 million. “Herceptin has the potential to save many women’s lives and I want to see it in widespread use on the NHS,” Ms Hewitt explained, adding that the move “represents a major step forward in the fight against cancer.”

Currently, the drug is only approved in Europe for the treatment of late-stage breast cancer, but a growing body of clinical trial data supports its potential for early-stage forms of the condition. The most recent results showed that adding the agent to chemotherapy significantly cuts the risk of cancer recurrence versus chemotherapy alone by as much as 51% [[04/10/05c]].

In response to growing pressure from campaign groups, Ms Hewitt ordered the UK drug watchdog, the National Institute for Health and Clinical Excellence, to fast track its evaluation of Herceptin’s wider use within the NHS earlier this year [[22/07/05d]]. But critics questioned whether the current system was up to the job of carrying out the testing, given the findings of a survey by cancer charity CancerBACUP last month that nearly a third of hospitals in England and Wales carry out no HER2 testing at all.

Herceptin has been a focal point for campaigners seeking earlier and more widespread access to new cancer drugs. The Fighting for Herceptin group said earlier this month that it would consider taking the Government to the High Court in an attempt to force it to make the drug available to early stage patients. And a major victory was scooped earlier this week when former nurse Barbara Clark won her battle to receive therapy with Herceptin on the NHS, after being told earlier this year that she was not eligible as her illness was not at the terminal stage [[04/10/05c]].

Commenting on Ms Hewitt’s decision, Professor John Toy of Cancer Research UK noted: "This shows that 'patient power' can move government to take pro-active decisions. Patients need to understand that the drug is not expected to be licensed until July 2006 at the earliest. A process to make the drug available as quickly as possible after licensing is especially important given this delay," reports BBC News Online.