Olema Pharmaceuticals announced it has aligned with the U.S. Food and Drug Administration, FDA, to select 90 mg of palazestrant as the dose for Part 2 of the ongoing registrational Phase 3 OPERA-01 trial in second- and third-line estrogen receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer. This update will be presented as part of the OPERA-01 trial-in-progress poster at the American Society of Clinical Oncology, ASCO, Annual Meeting taking place May 30-June 3 in Chicago, Illinois. The FDA also selected 90 mg of palazestrant in combination with the approved dose of CDK4/6 inhibitor ribociclib for the pivotal Phase 3 OPERA-02 trial in frontline ER+/HER2- metastatic breast cancer.
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