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Home Industry News Roche: Herceptin approved by EU for early stage breast cancer

Roche: Herceptin approved by EU for early stage breast cancer

24th May 2006

Herceptin has been has been approved for use in patients with early stage HER 2-positive breast cancer after surgery and standard chemotherapy by the European Commission.

Roche says that the decision is based on “remarkable” and “impressive” trial results which showed that Herceptin can reduce the risk of recurrence of the cancer by 46 per cent in comparison to chemotherapy alone. The company said that the ruling will now allow European women to use Herceptin, whether or not their breast cancer is in an advanced stage or not.

The company says that HER 2-positive breast cancer accounts for 20 to 30 per cent of women with breast cancer and it added that it can be a particularly aggressive form of the disease.

William M Burns, chief executive officer of Roche’s pharmaceuticals division, said: “The remarkably quick manner in which Herceptin has received European approval in early-stage breast cancer is commendable.”

“Herceptin has clearly demonstrated that it provides the best chance of long-term survival when used as early as possible in the course of the disease and this decision is great news for patients and the medical community,” he added.

Mr Burns concluded: “We will now work with national authorities to ensure that this treatment is accessible to physicians and patients throughout Europe.”

The National Institute for Health and Clinical Excellence (NICE), the UK’s drug approval body, has said that Herceptin is currently being fast-tracked through the review process and that it expects the decision to be released during July.

NICE chief executive, Andrew Dillon, explained that it is important the process is not rushed. He said: “Without these things, we risk exposing patients to risks and the health service to using its money unwisely.”

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