Roche files EU application for early stage Herceptin use

Roche has made an application for marketing approval for the use of Herceptin, also known as trastuzumab, in early stage breast cancer.

It announced Friday that it had filed for marketing authorisation with the European Medicines Agency (EMEA) for an indication covering treatment of the early stages of the HER2 positive form of the disease.

The drug has become the subject of controversy across the UK, with some local NHS authorities refusing to pay for the treatment ? despite evidence that the drug reduces the risk of cancer recurrence in 50 per cent of women who take it.

Herceptin does not yet have an EU-wide licence, meaning that primary care trusts retain discretion in funding the drug. Last week Swindon Primary Care Trust’s decision to refuse treatment to mother Ann Marie Rogers was upheld after a judge decided that the trust acted lawfully.

However, reports suggest that the government will fast-track the drug’s use across England and Wales once a licence is obtained.

“The outstanding benefits we have seen from Herceptin as post-surgical therapy for early-stage breast cancer underpin the importance of securing patient access to this drug as quickly as possible,” said Ed Holdener, head of Roche’s global pharma development.

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