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Herceptin set for approval

31st May 2006

06032006_herceptin1.jpgThe breast cancer drug Herceptin is set to be licensed for use in early stage disease by European regulators. A formal announcement about the drug, which could help some women with the disease, is expected to be made by the European Commission next week.

Last month, it was announced a committee at the European Medicines Agency (EMEA) had recommended the approval of Herceptin in a record 27 days. The process to license the drug for early stage breast cancer began in February when manufacturers Roche submitted its application to the European authorities. Herceptin is already used in the UK to treat women with advanced breast cancer.

Herceptin has been the subject of high profile legal battles by women seeking access to the drug for early stage breast cancer. In April, Ann Marie Rogers of Swindon, Wiltshire, won an Appeal Court ruling which, while it did not force primary care trusts to fund the drug, said it would be irrational to treat one patient and not another.

Following the appeal court ruling in April National Institute of Health and Clinical Excellence (NICE) Chief Executive Andrew Dillon reaffirmed the importance of ensuring that new drugs are both safe to use, by having an effective system for licensing, and used in the right way through the work that NICE does. Speaking on the pending EMEA decision he said that "Our appraisal of the clinical and cost effectiveness of Herceptin is already underway. We are keen to ensure that guidance is available in a matter of weeks."

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