Olema Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company, has announced that it has aligned with the U.S. Food and Drug Administration (FDA) to determine the appropriate dose of palazestrant for its pivotal clinical trials. The FDA has selected a 90 mg dose of palazestrant for both the Phase 3 OPERA-01 monotherapy trial and the Phase 3 OPERA-02 combination trial with ribociclib, focusing on ER+/HER2- metastatic breast cancer. This update will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting. The trials aim to address treatment resistance in metastatic breast cancer, and Olema anticipates top-line data from the OPERA-01 trial in 2026, with a potential commercial launch in 2027.
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