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Olema Oncology Receives FDA Fast Track Designation for OP-1250 for the Treatment of ER+ / HER2- Metastatic Breast Cancer
SAN FRANCISCO, July 21, 2022 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology,” Nasdaq: OLMA) today announced that the U.S. Food
About this update from Olema Pharmaceuticals, Inc.
[{"type":"text","content":"SAN FRANCISCO, July 21, 2022 (GLOBE NEWSWIRE) -- Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology,” Nasdaq: OLMA) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to OP-1250, the Company's novel, oral complete estrogen receptor (ER) antagonist (CERAN) and selective ER degrader (SERD), for the treatment of ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer that has progressed following one or more lines of endocrine therapy with at least one line given in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor. OP-1250 is currently being evaluated as a single agent in an ongoing Phase 1/2 clinical trial and in Phase 1b combination with palbociclib in patients with recurrent, locally advanced, or metastatic ER+/HER2- breast cancer. “Receiving Fast Track designation from the FDA for OP-1250 is an important milestone for the development program and underscores OP-1250’s potential clinical utility to address a significant unmet medical need in women living with advanced ER+/HER2- breast cancer,” said Sean P. Bohen, M.D., Ph.D., President and Chief Executive Officer of Olema Oncology. “We look forward to working closely with the FDA to optimize and expedite the development program, with the goal of making OP-1250 available to patients sooner.” Fast Track is an FDA process designed to facilitate the development and expedite the review of potential therapies that seek to treat serious conditions and fill an unmet medical need. A drug candidate that receives Fast Track designation is eligible for more frequent communication with the FDA throughout the drug development process for the purpose of expediting the drug's development, review, and potential approval. Additionally, the designation allows for eligibility for and a rolling and/or priority review of its marketing application if relevant criteria are met. About Olema Oncology Olema Oncology is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of targeted therapies for women’s cancers. Olema’s lead product candidate, OP-1250, is an orally-available small molecule with combined activity as both a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD). It is currently being evaluated as a ...