FDA Priority Review accepted for giredestrant in early stage breast cancer
KEY STEPOn June 2, 2026, Roche announced that the United States FDA accepted the New Drug Application for giredestrant under Priority Review as adjuvant treatment for adults with ER positive, HER2 negative stage I, II and III breast cancer. The filing is based on the Phase III lidERA study, which reported a 30 percent reduction in the risk of invasive disease recurrence or death versus standard endocrine therapy. The FDA set a decision date of November 30, 2026.
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