Hot off the press:Herceptin approved for early breast cancer in EU

[Lani]

Herceptin given European approval

The drug is already used for advanced cancer
The breast cancer drug Herceptin has been licensed for use in the early stages of the disease by European regulators.
The decision by the European Medicines Agency has been made earlier than expected.

The NHS drugs watchdog has now pledged to complete its fast-track appraisal of the drug "within weeks".

The National Institute of Health and Clinical Excellence will rule if the drug is safe and cost-effective.


This is great news and should persuade any hesitating doctor or PCT to offer Herceptin to suitable patients
Jeremy Hughes, Breakthrough Breast Cancer

Last month, it was announced a committee at the 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.

The drug is already used in the UK to treat women with advanced breast cancer.

But there has been pressure to use the drug to treat women with an earlier stage of the disease.

A year's course of the drug, which targets the HER-2 protein which can fuel the growth of breast tumours, costs around £20,000.

Around a fifth of breast cancers are HER-2 positive.

Appeal Court ruling

Herceptin has been the subject of high profile legal battles by women seeking access to the drug.

In April, Ann Marie Rogers of Swindon, Wiltshire, won an Appeal Court ruling forcing her local primary care trust to fund the treatment.

Although that ruling does not force all trusts to fund the drug, it did say it would be irrational to treat one patient with it and not another.

But lawyers argued the judgment still left the door open for primary care trusts to refuse to fund it if they provided a rational argument.

Health Secretary Patricia Hewitt intervened in the debate last October to say NHS bodies should not withhold the drug on cost grounds from patients whose doctors had recommended it.

However, there have been concerns that Herceptin's effectiveness is over-hyped

'Wealth of evidence'

Andrew Dillon, chief executive of NICE, said: "Our appraisal of the clinical and cost effectiveness of Herceptin is already underway.

"We are working hard to ensure our review is completed as soon as possible and we will update our timelines following the earlier than anticipated granting of the licence.

"We are keen to ensure that guidance is available in a matter of weeks."

Barbara Clark, 50, from Bridgwater, Somerset, who won her case to receive the drug on the NHS last October, welcomed the EMEA's decision.

She said: "I feel this is the end of a tremendous fight. It's great news."

Jeremy Hughes, chief executive of Breakthrough Breast Cancer, said: "This is great news and should persuade any hesitating doctor or PCT to offer Herceptin to suitable patients.

"The full license confirms that Herceptin is safe and effective in early breast cancer.

"The wealth of evidence available together with this licensing decision, will reassure those who were previously cautious about prescribing a drug that wasn't licensed for early breast cancer."

Joanne Rule, chief executive of Cancerbackup, said: "Breast cancer patients across England and Wales are currently experiencing a dreadful postcode lottery; denied Herceptin because of where they live or how 'exceptional' their lives are deemed to be.

"This can stop now."