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Roche have accused the Irish regulator of deliberately blocking life-saving treatment to breast cancer patients. According to the drug maker, Ireland is deviating from accepted approval processes in the US and other EU states for assessing the effectiveness of new drugs. This specifically applies to the acceptance of the eradication of cancer tumours as an endpoint in evaluating the effectiveness of new drugs. Roche are claiming the HSE’s refusal to approve Perjeta for use prior to surgery in early breast cancer is the first time it has experienced this in 50 years in Ireland. Perjeta, which treats women with HER2-positive breast cancer, could benefit 1,000 patients over five years and Roche estimate that 178 of these would have their tumours eradicated.