The Fighting for Herceptin Group, an organization solely focused on increasing access to Roche’s Herceptin (trastuzumab) for women with early-stage breast cancer in the UK, have failed to get the government to approve wider use of the drug, after bringing a petition containing 34,000 signatures to its door.

According to BBC News Online, Health Minister Rosie Winterton said greater access would depend on a wider licence for the drug. “Although preliminary results on the use of Herceptin for early breast cancer are encouraging, more work needs to be done to be certain that the benefits of this treatment for this group of patients outweigh any potentially damaging side-effects. That is why there is a robust process for analysing any drug’s safety before it can be licensed,” she expained, adding: “Once a drug is licensed, we expect Primary Care Trusts to take full account of the available evidence when reaching funding decisions. With record funding going into the NHS, where the evidence is very strong, there is no reason to believe a PCT would refuse funding.”

Currently, the drug is only prescribed on the NHS to women with advanced-stage breast cancer, despite a growing body of sound clinical evidence showing that early administration of the agent dramatically decreases the chances of disease recurrence while significantly increasing life span.

Most recently, a large-scale Phase III study of Herceptin (trastuzumab) in early-stage breast cancer, a particularly aggressive form of the disease, demonstrated that adding the agent to chemotherapy significantly cuts the risk of cancer recurrence versus chemotherapy alone, by as much as 51% [[14/09/05d]].

“Since launching this campaign, it’s become clear to me that there are thousands of women out there that could be benefiting from this drug. A generation of women are being taken away from their children because the government refuses to fund Herceptin. This is in spite of massive evidence that in early breast cancer it can even stop the cancer from returning,” campaign leader Dorothy Griffiths told BBC News Online.

The campaigners are reportedly also taking their cause to the High Court. An article in local UK newspaper, The Sentinel, claims that the Group is getting ready to sue four primary care trusts - Stoke North, Stoke South, Newcastle and Central Cheshire, in a joint claim managed by Solicitors Bindman & Partners. The suit will only be launched if a final request to provide the drug to patients is denied - on the grounds that Herceptin is not yet approved for this indication by the European Medicines Agency or the National Institute of Clinical Excellence.

Earlier this year, Health Secretary Patricia Hewitt ordered NICE to speed up its assessment of Herceptin, after UK charity CancerBACUP warned that the agent may not be available until 2007 on the NHS [[22/07/05d]].

In response to the Group’s action and growing publicity surrounding the case, the European Medicines Agency took the unusual step of releasing a statement explaining that it has not yet received any application for the use of the product for early-stage breast cancer, but that it believes that Roche is preparing such a submission for the beginning of 2006. It went on to say that previous similar submissions in important oncology indications have been dealt with by the Agency in an expedited review within two to three months.