Roche announces that the EC has approved Herceptin (trastuzumab) for patients with early-stage HER2-positive breast cancer following surgery and standard chemotherapy. HER2-positive breast cancer, which affects approximately 20 per cent to 30 per cent of women with breast cancer, demands special and immediate attention because the tumours are fast-growing and there is a higher likelihood of relapse.
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 per cent compared to chemotherapy alone.
"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 throughout Europe," he added.
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 organizations around the world to act urgently to ensure access to Herceptin for early-stage HER2-positive breast cancer patients. Herceptin was recently granted approval status in New Zealand and Australia, and several countries over the past year have developed clinical guidelines and committed funding to allow eligible patients faster access, prior to license.
In the US, Genentech filed a supplemental Biologic License Application (sBLA) for the use of Herceptin in early-stage HER2-positive breast cancer with the FDA on February 15th, 2006. The application is based on data from the combined interim analysis of two large US trials, 4 and Genentech has received a priority review designation.