FDA Grants Priority Review to Giredestrant in ER+/HER2– Early Breast Cancer
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The FDA has granted priority review to giredestrant for the treatment of early breast cancer that is estrogen receptor-positive and HER2-negative. The application is for a potential treatment to reduce the risk of recurrence or death in this type of breast cancer, with some reports suggesting it may lower this risk by a significant percentage. The review is for a new drug application submitted by Genentech, a company owned by Roche, for an oral medication that has shown positive results in phase III trials.
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