FDA Approves Stemline’s Orserdu for Several Forms of Breast Cancer
The FDA has approved Stemline Therapeutics’ Orserdu (elacestrant) as the first treatment for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer who have experienced disease progression after at least one line of endocrine therapy.
Orserdu is an estrogen receptor antagonist that blocks estrogen activity.
Orserdu received Priority Review and Fast Track designations from the FDA based on the results of a phase 3 trial that demonstrated statistically significant progression-free survival (PFS) with elacestrant vs. standard of care endocrine monotherapy (fulvestrant, letrozole, anastrozole, exemestane), meeting both primary endpoints in all patients and in those patients whose tumors harbor ESR1 mutations.
ESR1 mutations are present in up to 40 percent of ER-positive and HER2-negative advanced or metastatic breast cancer.
Stemline Therapeutics is a Menarini Group subsidiary. Menarini acquired the rights to elacestrant from Radius Health in July 2020.
About ORSERDU (elacestrant)
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. The Marketing Authorization Application (MAA) is currently under review by the European Medicines Agency (EMA).
Elacestrant is also being investigated in several clinical trials in metastatic breast cancer disease, alone or in combination with other therapies: ELEVATE (NCT05563220); ELECTRA (NCT05386108); ELONA (NCT05618613); ELCIN (NCT05596409). Elacestrant is also planned to be evaluated in early breast cancer disease.
StemlineTherapeutics Inc.
Stemline, biotechnology company is part of the Menarini Group, a leading international pharmaceutical and diagnostics company, with a turnover of over $4 billion and over 18,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia.
Stemline Therapeutics, a wholly-owned subsidiary of the Menarini Group, is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics. Stemline commercializes Elzonris®, a novel targeted treatment directed to CD123 for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare hematologic cancer, in the United States and Europe, the only approved treatment for BPDCN in the US and EU to date. Stemline also commercializes Nexpovio® in Europe, an XPO1 inhibitor for multiple myeloma originating from a licensing deal with Karyopharm. Stemline has an extensive clinical pipeline of small molecules and biologics in various stages of development for a host of solid and hematologic cancers.
January 31, 2023
