Switzerland’s Roche has today submitted a dossier for the eagerly-awaited use of Herceptin (trastuzumab) in early breast cancer to the European Medicines Agency, including data from two pivotal studies showing it can halve the risk of tumour recurrence when added to standard treatment regimens. The move follows in the wake of a similar submission by partner Genentech in the USA this week.

Herceptin is one of Roche’s biggest selling drugs, with sales pushing over the 2 billion Swiss franc ($1.5 billion) mark last year. In the UK, the drug has reached almost mythical status, with patients taking primary care trusts to court to try and secure access for early breast cancer on the country’s National Health Service – a thus far unapproved indication. In two cases, the UK’s Health Secretary, Patricia Hewitt, intervened to overrule the PCTs in question, triggering huge debate about whether political pressure should be able to bypass the usual regulatory safety nets put in place to protect patients. However, in the most recent case, a 54-year-old early breast cancer sufferer lost a battle in London's High Court over her PCT’s refusal to shell out for the drug.

In October, Hewitt ordered that women diagnosed with early-stage breast cancer be tested for suitability to receive treatment with Herceptin. If the EMEA grants the expanded license, Herceptin will be fast-tracked for use throughout the National Health Service. Until now, it has only been available for patients with advanced disease.

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."