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news.The European Commission has approved Roche's Herceptin for patients with early-stage HER2-positive breast cancer following surgery and standard chemotherapy.
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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 tumors are fast-growing and there is a higher likelihood of relapse.
The approval is based on impressive results from the international HERA study, which showed Herceptin (trastuzumab) following standard chemotherapy significantly reduces the risk of cancer coming back by 46% compared to chemotherapy alone. Similarly remarkable benefits have also been observed 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 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.”
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 the treatment.