Posted by Michael Wonder on 21 Jul 2022
Olema Oncology receives FDA fast track designation for OP-1250 for the treatment of ER positive, HER2 negative metastatic breast cancer
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.
