New Herceptin results confirm impressive reduction in risk of cancer returning

September 14, 2005

New Herceptin results confirm impressive reduction in risk of cancer returning in women with aggressive form of early-stage breast cancer. Fourth large phase III trial establishes and confirms Herceptin's superiority to chemotherapy alone

New Herceptin results confirm impressive reduction in risk of cancer returning in women with aggressive form of early-stage breast cancer

Fourth large phase III trial establishes and confirms Herceptin's superiority to chemotherapy alone

Roche announced today that a fourth large phase III trial in early-stage HER2-positive breast cancer has shown that adding Herceptin (trastuzumab) to chemotherapy significantly reduces the risk of cancer coming back compared to chemotherapy alone. This study follows three earlier phase III studies which also confirmed Herceptin's superiority to chemotherapy alone in early-stage breast cancer. HER2-positive breast cancer is a particularly aggressive form of the disease which affects approximately 20 - 30% of women with breast cancer.[a]

"The results from Herceptin's development programme in early breast cancer have been nothing less than remarkable, commented William M. Burns, CEO of Roche's Pharmaceuticals Division. "Four large trials in the past five months have delivered outstanding efficacy and safety from a vast patient pool and with a variety of treatment regimens, more than two years earlier than planned. Roche, the medical community and regulatory authorities around the world are urgently working together to secure access to Herceptin for early-stage HER2-positive breast cancer patients as soon as possible, and filing in Europe could happen as early as the beginning of 2006.\\\

Ketchum

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