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17/02/2006
Herceptin manufacturer applies for license
The manufacturer of breast cancer drug Herceptin has applied for a license to allow the drug to be used to treat patients in the early stages of the disease.
Herceptin is currently used to treat patients in the advanced stages of breast cancer. However, the drug's manufacturer, Roche, has claimed that the drug halves the risk of the aggressive HER-2 form of the cancer, which affects between 20 - 30% of sufferers, from returning.
Herceptin was licensed for the treatment of patients with advanced breast cancer in March 2002. Roche has now submitted an application to the European Medicines Agency (EMEA) to allow the drug to be used to treat patients in the early stages of the disease.
Guidance from the National Institute for Health and Clinical Excellence will also be fast-tracked. The government has said that the drug will be fast-tracked in England once an early stage license has been received.
A spokesperson for Roche said today: "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."
The announcement comes after a woman lost her legal bid to be provided the drug, which can cost as much as £21,000 for a year's treatment, on the NHS.
Mother-of-three Ann Marie Rogers lost her High Court battle on Wednesday.
Swindon Primary Care Trust refused to pay for the drug for Ms Rogers, saying that her case was not "exceptional" and that they were acting in accordance with government guidelines.
Ms Rogers, 53, has early stage cancer. During the hearing, she told the court if she did not receive the drug it would be like being given a "death sentence".
NHS funding of Herceptin has been criticised as a "postcode lottery", with some health authorities paying for all eligible applicants, while other fund only exceptional cases.
Last year, Barbara Clarke and Elaine Barber received Herceptin after threatening to take their primary care trusts to court.
(KMcA)
Herceptin is currently used to treat patients in the advanced stages of breast cancer. However, the drug's manufacturer, Roche, has claimed that the drug halves the risk of the aggressive HER-2 form of the cancer, which affects between 20 - 30% of sufferers, from returning.
Herceptin was licensed for the treatment of patients with advanced breast cancer in March 2002. Roche has now submitted an application to the European Medicines Agency (EMEA) to allow the drug to be used to treat patients in the early stages of the disease.
Guidance from the National Institute for Health and Clinical Excellence will also be fast-tracked. The government has said that the drug will be fast-tracked in England once an early stage license has been received.
A spokesperson for Roche said today: "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."
The announcement comes after a woman lost her legal bid to be provided the drug, which can cost as much as £21,000 for a year's treatment, on the NHS.
Mother-of-three Ann Marie Rogers lost her High Court battle on Wednesday.
Swindon Primary Care Trust refused to pay for the drug for Ms Rogers, saying that her case was not "exceptional" and that they were acting in accordance with government guidelines.
Ms Rogers, 53, has early stage cancer. During the hearing, she told the court if she did not receive the drug it would be like being given a "death sentence".
NHS funding of Herceptin has been criticised as a "postcode lottery", with some health authorities paying for all eligible applicants, while other fund only exceptional cases.
Last year, Barbara Clarke and Elaine Barber received Herceptin after threatening to take their primary care trusts to court.
(KMcA)
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