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"HER2-positive breast cancer, which affects approximately 20% to 30% of women with breast cancer, demands special and immediate attention because the tumours are fast-growing and there is a higher likelihood of relapse," said the press release from Roche.
The approval is based on impressive results from the international HERA (HERceptin Adjuvant) study which showed Herceptin following standard chemotherapy significantly reduces the risk of cancer coming back by 46% compared to chemotherapy alone. Similar benefits have also been seen in three other major global and US studies.
"The remarkably quick manner in which Herceptin has received European approval in early-stage breast cancer is commendable" commented William M. Burns, CEO of Roche's Pharmaceuticals Division. "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. We will now work with national authorities to ensure that this treatment is accessible to physicians and patients."
Herceptin was previously approved in the EU for the treatment of metastatic (advanced) HER2-positive breast cancer, so this new approval allows women with all stages of this aggressive disease, including early-stage breast cancer, to access this life-extending treatment option. The strength of results from four large trials with over 12 000 patients has influenced medical and regulatory organisations around the world to act urgently to ensure access to Herceptin for early-stage HER2-positive breast cancer patients.
"Since 1998, Herceptin has been used to treat over 230 000 HER2-positive breast cancer patients worldwide," the statement said. – (Health24)
Source: Press release from Roche
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June 2006
