Roche’s Perjeta Wins Approval for Early Breast Cancer
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Roche Holding AG’s Perjeta won expanded U.S. approval as the first pre-surgical therapy in breast cancer, increasing the odds the disease may be stopped in those diagnosed with early stage HER2-positive tumors.
Perjeta, which is to be used in combination with Basel, Switzerland-based Roche’s older breast cancer medicine Herceptin and chemotherapy, was approved under an accelerated process based on early clinical trials that showed the therapy reduced the size of tumors, the Food and Drug Administration said today in a statement. Roche must complete a trial confirming benefit in more than 4,800 enrollees who have had prior breast cancer surgery and are at high risk of their cancer returning, the FDA said.