21.07.2022 14:35:44

Olema Pharma Receives Fast Track Designation From FDA For OP-1250

(RTTNews) - Olema Pharmaceuticals, Inc. (OLMA) announced the FDA has granted Fast Track designation to OP-1250 for the treatment of ER+, human epidermal growth factor receptor 2-negative 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 4/6 inhibitor. OP-1250 is currently being evaluated as a single agent in an ongoing phase 1/2 trial and in phase 1b combination with palbociclib in patients with recurrent, locally advanced, or metastatic ER+/HER2- breast cancer.

Sean Bohen, President and CEO of Olema Oncology, said: "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."

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