FLORENCE, Italy & NEW YORK–(BUSINESS WIRE)–The Menarini Group (“Menarini”), a private Italian pharmaceutical and diagnostics company, and Stemline Therapeutics (“Stemline”), a wholly owned subsidiary of the Menarini Group, today announced that the EMA had validated the marketing authorization application (MAA) for elacestrant, a selective estrogen receptor degrader (SERD), for patients with advanced or metastatic ER+/HER2- breast cancer. Validation of the application confirms that the submission is complete and initiates EMA’s centralized review process.
“There is a major unmet need in the treatment of advanced or metastatic ER+/HER2- breast cancer after the emergence of resistance in the first lines of treatment,” commented Elcin Barker Ergun, Chief Executive Officer of the Menarini Group. “The acceptance of our application for review by the EMA represents an important milestone for our company and we look forward to working with the agency to potentially bring elacestrant to patients with advanced or metastatic breast cancer from second and third line ER+/HER2-. in Europe.”
The Phase 3 EMERALD study (NCT03778931) evaluated elacestrant versus SOC endocrine monotherapy (investigators’ choice of either fulvestrant or an aromatase inhibitor) in patients with advanced breast cancer or metastatic ER+/HER2-. The results of the study were recently published online in the Journal of Clinical Oncology (JCO) on May 18, 2022. Further post-hoc analyzes of the study will be presented at the European Society for Medical Oncology (ESMO) Congress 2022 to be held September 9-13, 2022 in Paris, France.
The Menarini Group obtained worldwide licensing rights for elacestrant in July 2020 from Radius Health, Inc, which successfully conducted and completed the EMERALD study. Based on the positive Phase 3 data, Stemline submitted an MA to the EMA on July 27, 2022. Regulatory review of elacestrant is also underway in the United States, with the Food and Drug Administration (FDA) having recently accepted a new drug application for the designation of elacestrant. a priority review. The Menarini Group is now fully responsible for the worldwide registration, commercialization and further development of elacestrant.
About Elacestrant (RAD1901) and the EMERALD Phase 3 Study
Elacestrant is an investigational Selective Estrogen Receptor Degrader (SERD). In 2018, elacestrant received Fast Track designation from the FDA. Preclinical studies performed prior to EMERALD indicate that the compound has the potential to be used as a single agent or in combination with other therapies for the treatment of breast cancer. The Phase 3 EMERALD trial is a randomized, open-label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in patients with advanced/metastatic ER+/HER2- breast cancer. The study recruited 477 patients who had received prior treatment with one or two lines of hormone therapy, including a CDK 4/6 inhibitor. Study patients were randomized to receive either elacestrant or an approved hormonal agent of the investigator’s choice. The primary endpoint of the study was progression-free survival (PFS) in the overall patient population and in patients with the estrogen receptor 1 gene (CSR1) mutations. Secondary endpoints included assessment of overall survival (OS), objective response rate (ORR), duration of response (DOR), and safety.
About the Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics company, with sales of over $4 billion and more than 17,000 employees. Menarini focuses on therapeutic areas with high unmet need with products for cardiology, oncology, pulmonology, gastroenterology, infectious diseases, diabetes, inflammation and analgesia. With 18 production sites and 9 Research and Development centers, Menarini products are available in 140 countries around the world. For more information, please visit www.menarini.com.
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 treatments. Stemline is commercializing a new CD123-directed targeted therapy in the United States and Europe for patients with blast plasmacytoid dendritic cell neoplasm (BPDCN), which is also being evaluated as monotherapy and in combination with other agents, in additional clinical trials for various other indications. . Stemline has an extensive clinical portfolio of small molecules and biologics in various stages of development for a multitude of solid and hematological cancers.
Radius is a global biopharmaceutical company focused on unmet medical needs in the areas of bone health, neuro-orphan diseases and oncology. Radius’ lead product, TYMLOS® (abaloparatide) Injection, has been approved by the US Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk of fracture.