Olema Oncology receives FDA fast track designation for OP-1250 for the treatment of ER positive, HER2 negative metastatic breast cancer

Olema Pharmaceuticals

21 July 2022 - Olema Pharmaceuticals today announced that the U.S. FDA has granted fast track designation to OP-1250, the Company's novel, oral complete oestrogen receptor antagonist and selective oestrogen receptor degrader, for the treatment of oestrogen receptor positive, 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 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 positive, HER2 negative breast cancer.

Read Olema Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , US , Fast track