January 30, 2023

The Menarini Group, a leading Italian pharmaceutical and diagnostics company, has announced 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. Orserdu is approved under the FDA’s Priority Review and Fast Track designation.

  • 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.

Stemline Therapeutics (“Stemline”), a wholly-owned subsidiary of the Menarini Group, headquartered in New York will commercialize Orserdu in the U.S.

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