Roche seeks licence for cancer drug in early stage breast cancer treatment

Roche seeks licence for cancer drug in early stage breast cancer treatment

	Published : Sat, 18 Feb 2006 17:10 By : Richard Owen Print this Story

LONDON: Drug maker Roche has filed an application with the European Medicines Agency for licence to market its breast cancer drug Herceptin for treatment of early stages of the disease.

The company said its research on the drug has shown it halves the risk of the HER-2 form of cancer returning if it is used in early stage.

Roche's decision apparently stems from the case of Ann Marie Rogers, who lost her legal battle to have the drug included in the NHS so that she can avail of its benefits.

The government has given assurance that once the drug is licensed, it would be fast-tracked in Britain.

Rogers, mother-of-three, has been given leave to appeal against the court's decision, and will be able to receive Herceptin treatment until then. The cost of a year's treatment using Herceptin is 19,500 pounds.

Herceptin is currently licensed for use in women with advanced breast cancer, where the malignancy has spread within the breast or to another organ. However, Roche claimed its research has shown that administration of Herceptin, followed by chemotherapy in early-stage HER2-positive breast cancer, reduced the risk of the cancer coming back by an "outstanding 46 per cent". HER-2 form of cancer affects around 20 to 30 per cent women with breast cancer.

The judge, giving a ruling, said Swindon Primary Care Trust, which had refused to fund Rogers' treatment, had not been acting unlawfully.

The NHS funding process for early stage treatment with Herceptin has been erratic. While some health authorities have opted to pay for all eligible applicants, others have funded the drug's use only in "exceptional cases". It has been mainly because of the lack of licence to use it in early stages of breast cancer. In Rogers' case, Swindon Primary Care Trust adopted the latter policy.

Meanwhile, the National Institute for Health and Clinical Excellence, which advises on best practice for the NHS in England and Wales, has begun a fast-track assessment of the drug, which will ensure that its appraisal is under way before a licence is granted.

Ed Holdener, head of Roche’s global pharma development, said the outstanding benefits of Herceptin as post-surgical therapy for early-stage breast cancer underpin the importance of securing patient access to this drug as quickly as possible. “We are very pleased to have been able to progress this application so rapidly, and commend the medical community and regulatory authorities worldwide for their close collaboration and continued support.”