- The U.S. Food and Drug Administration (FDA) granted fast track designation to Olema Pharmaceuticals' ( NASDAQ: OLMA ) OP-1250 to treat certain patients with breast cancer.
- Specifically, the FDA designation for OP-1250 is to treat ER-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer that has progressed after one or more lines of endocrine therapy with at least one line given in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor.
- The company OP-1250 is currently being evaluated as a single agent in a phase 1/2 trial and in phase 1b study as a combination with palbociclib to treat certain patients breast cancer.
- OLMA +12.31% to $5.29 premarket July 21
For further details see:
Olema stock soars 12% as FDA grants fast track status to OP-1250 for breast cancer subtype