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EMEA committee backs Herceptin

CHMP decision could pave the way for wider use of breast cancer drug in Europe

Roche and Genentech's breast cancer drug, Herceptin, could be made more widely available in Europe after European regulators endorsed its use in early stages of the disease.

The Committee for Medicinal Products for Human Use (CHMP) at the European Medicines Agency (EMEA) adopted a positive opinion for the controversial drug.

Herceptin has been the subject of high profile court battles by women seeking to receive it on the NHS for early-stage breast cancer. However, some Primary Care Trusts (PCTs) in the UK have continued to refuse patients access to the treatment saying that recent research has suggested the drug's benefits are not as great as first thought.

The CHMP's positive opinion was made in a record 27 days and paves the way for EMEA to issue a licence for Herceptin within 90 days. The drug is already licensed for use in advanced breast cancer cases.

ìThe CHMP's timely decision represents a significant milestone, bringing patients and the medical community one step closer to broadly accessing this effective therapy in the EU,î said Ed Holdener, head of Roche's global pharma development.

UK medicines cost-effectiveness body, the National Institute for Health and Clinical Excellence (NICE), is currently assessing whether to recommend the drug for early-stage breast cancer through the NHS on a fast-track appraisal process. A NICE spokesman said the agency should make a preliminary decision by August.

Herceptin costs around £20,000 a year per patient. Although PCTs that have refused to supply the treatment have not raised the drug's price as an issue, most patients say they believe cost was the main sticking point.

In February, Roche and Genentech asked the US Food and Drug Administration (FDA) to approve Herceptin for early-stage breast cancer. The US regulator said it had granted the application `priority review' status, which means it must come to a decision within six months.

30th September 2008

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