The European Medicines Agency has approved Roche’s Herceptin for patients with early-stage breast cancer, giving doctors in Europe the nod to use the drug in the millions of women diagnosed with early-stage disease every year.
The EMEA cleared the drug for early-stage HER-2-positive breast cancer, a particularly aggressive form of the disease accounting for 20% to 30% of all cases, following surgery and standard chemotherapy.
The approval is based on impressive results from the HERA study which showed Herceptin following standard chemotherapy reduced the risk of cancer returning by 46% compared to chemotherapy alone.
The chief executive of Roche’s pharmaceuticals division, William Burns, welcomed the rapid approval, which came just a month after the Committee for Medicinal Products for Human Use (CHMP) backed approval after a review of just 27 days. “We will now work with national authorities to ensure that this treatment is accessible to physicians and patients throughout Europe.”
Herceptin was previously approved in the EU for the treatment of metastatic (advanced) HER2-positive breast cancer, so this new approval allows women with all stages of this aggressive disease, including early-stage breast cancer, to access this life-extending treatment option.
That said, EU approval is just one of the hurdles that Roche must vault in expanding access to the drug, which has captured the imagination of patients – who clamour for access to it – but has a price tag of more than £20,000 a year that presents problems for cash-strapped healthcare systems.
The UK is a prime example of this, with patients taking legal action to try to force Primary Care Trusts to provide access to the drug, and the National Institute for Health and Clinical Excellence under pressure to deliver a verdict on whether the drug is cost-effective enough to be prescribable under the National Health Service. A decision is expected in July.
Herceptin is Roche’s third-biggest product, bringing in around $1.8 billion in sales last year, almost 50% ahead of 2004’s tally.
Herceptin was recently granted approval for this indication in New Zealand and Australia, and several countries over the past year have developed clinical guidelines and committed funding to allow eligible patients faster access to the drug, prior to license. Meanwhile, in the USA Genentech filed for approval of Herceptin in early-stage HER2-positive breast cancer with in February, with a verdict expected by August.
- In other news, Roche signed a deal with US company Entelos to use the latter’s ‘virtual patient’ platform, a mathematical model of human physiology which predicts how a drug will behave before it is tested in man. The project will focus on drugs to treat chronic metabolic disorders, including diabetes and obesity.