Context Partner Stemline, a Menarini Unit, Gets FDA OK of ORSERDU for Breast Cancer

 First endocrine innovation in more than 20 years which has shown improved efficacy over standard-of-care treatments in patients with advanced breast cancer

ORSERDU is being evaluated in combination with Context’s ONA-XR in the ongoing ELONA trial

Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a company developing novel treatments for solid tumors, with a primary focus on female cancers, today announced that its clinical trial collaborator, Stemline Therapeutics, Inc., a wholly owned subsidiary of The Menarini Group (“Menarini”), received approval from the U.S. Food and Drug Administration (FDA) for ORSERDU (elacestrant) for the treatment of postmenopausal women or adult men with estrogen receptor–positive (ER+), HER2-negative (HER2-), Estrogen Receptor 1 gene (ESR1)-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. ORSERDU has shown improved efficacy over the current standard-of-care (SOC) treatment, fulvestrant, in patients with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer.

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