Roche’s phenomenally successful breast cancer drug Herceptin (trastuzumab) has been pushed through the European approvals system in record time and now looks set to be made available to the millions of women diagnosed with early-stage disease every year. The thumbs-up from the European Medicines Agency’s advisory committee, the Committee for Human Medicinal Products, was given in just 27 days.
Specifically, the CHMP has given Roche the green light to market Herceptin following surgery and standard chemotherapy in women whose cancer is classed as positive for the HER-2 receptor - an aggressive form of the disease in which the tumours are fast-growing and there is a higher likelihood of relapse. Full marketing clearance from the European Medicines Agency is anticipated within the next three months.
The decision has been based on data the New England Journal of Medicine described as “revolutionary,” showing that Herceptin effectively halved the risk of tumour recurrence in women with early breast cancer.
In the UK, Herceptin has become a brand-name to be reckoned with as patients clamour for access to the drug – which comes with a price tag in excess of £20,000 per year – and politicians and regulators juggle with what has become somewhat of a hot potato.
On the one hand, Health Secretary Patricia Hewitt has called for greater access to Herceptin – even for the non-approved indication of early breast cancer – while the National Health Service struggles to stump up the money amid a deepening cash crisis. And patients have taken their primary care trusts to the High Court to secure treatment with the drug; most recently, Anne Marie Rogers won her legal battle after Swindon PCT refused to pay for her therapy.
In the middle of all this is the country’s cost-effectiveness body, the independent National Institute for Health and Clinical Excellence, which has the job of assessing whether Herceptin should be made available on the NHS. Hewitt’s intervention led to the Institute building in a fast-track system to allow speedier decisions to be made; it began the process as soon as Roche submitted its application to the European regulators in February and says it expects to make what is perhaps the most politically sensitive recommendation of its existence in July.
Herceptin, which is already available for advanced breast cancer, saw a doubling of its turnover during the first three months of this year to in excess of 860 million Swiss francs ($686 million).