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European Medicines Agency (EMEA) Recommends Herceptin For Early Stage Breast Cancer

The European Medicines Agency (EMEA) has recommended the use of breast cancer drug Herceptin in early stages of the cancer in a record 27 days review//. A license for the drug is to be issued in three months time.

The National Institute of Health and Clinical Excellence in the UK will decide now if Herceptin can be recommended in the NHS. The drug, which costs £20,000 a year, is already being fast tracked by NICE. "We will be able to issue national guidance to the NHS on the use of Herceptin within weeks of the drug being licensed for safety by the EMEA," said Andrew Dillon, NICE chief executive.

Herceptin is already licensed for use in advanced breast cancer. But some trials showed that it is useful in early stages as well and the UK has seen a number of women drag NHS trusts to court over refusal to fund the drug. Health Secretary Patricia Hewitt had said last October that NHS bodies must not refuse the drug, if the doctors had recommended it.

But NHS trusts continued to refuse the drug, forcing patients to seek refuge in court. Ann Marie Rogers of Swindon, Wiltshire won a case earlier this month ruling forcing her local primary care trust to fund Herceptin. The news of Herceptin's approval by the EMEA was welcomed by charity Breakthrough Breast Cancer, "Not only does this confirm the drug's importance, it should also help reassure those who may have previously doubted its effectiveness and safety," said Chief executive Jeremy Hughes. "We hope that in light of today's decision, any PCT still wavering about prescribing Herceptin, should now have the confidence to make it available to all for whom it is recommended."


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