Olema Pharmaceuticals Announces FDA Alignment on 90 mg Palazestrant Dose for Phase 3 Trials in Metastatic Breast Cancer

Reuters
05-28
Olema Pharmaceuticals Announces FDA Alignment on 90 mg Palazestrant Dose for Phase 3 Trials in Metastatic Breast Cancer

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.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Olema Pharmaceuticals Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9458726-en) on May 28, 2025, and is solely responsible for the information contained therein.

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