- ESR1 mutations are present in up to 40% of ER+, HER2- advanced or metastatic breast cancers.
- ESR1 mutations are a known driver of resistance to standard endocrine therapy, and so far, have been difficult to treat.
- ORSERDU is the first endocrine innovation in more than 20 years, specifically addressing ESR1 mutations, a major unmet need.
FLORENCE (Italy) and New York City (U.S.) January 30th, 2023 – The Menarini Group (“Menarini”), a leading Italian pharmaceutical and diagnostics company, announced today that the U.S. Food and Drug Administration (FDA) has approved ORSERDU for the treatment of postmenopausal women or adult men, with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. Stemline Therapeutics (“Stemline”), a wholly-owned subsidiary of the Menarini Group, headquartered in New York and focused on bringing transformational oncology treatments for cancer patients, will commercialize ORSERDU in the U.S.
Read the complete statement and information HERE.