Le Lézard
Classified in: Health, Science and technology
Subjects: TRI, IMA

Menarini Group's Elacestrant Marketing Authorization Application Accepted for Review by the European Medicines Agency (EMA) for the Treatment of ER+/HER2- Advanced or Metastatic Breast Cancer


FLORENCE, Italy and NEW YORK, Aug. 19, 2022 /CNW/ -- The Menarini Group ("Menarini"), a privately held Italian pharmaceutical and diagnostics company, and Stemline Therapeutics ("Stemline"), a wholly-owned subsidiary of the Menarini Group, today announced that EMA has validated the Marketing Authorization Application (MAA) for elacestrant, a selective estrogen receptor degrader (SERD), for patients with ER+/HER2- advanced or metastatic breast cancer. Validation of the application confirms the submission is complete and begins EMA's centralized review procedure.

Menarini Industrie Farmaceutiche Riunite Logo

"There is a major unmet need in the treatment of advanced or metastatic ER+/HER2- breast cancer after resistance builds in the earlier 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 a significant step for our company and we look forward to working with the agency to potentially bring elacestrant to patients suffering from second and third line ER+/HER2- advanced or metastatic breast cancer in Europe."

The Phase 3 EMERALD study (NCT03778931) evaluated elacestrant compared to SOC endocrine monotherapy (investigators' choice of either fulvestrant or an aromatase inhibitor) in ER+/HER2- advanced or metastatic breast cancer patients. The study results were recently published online in the Journal of Clinical Oncology (JCO) on May 18, 2022. Further post-hoc analysis from the study will be presented at the European Society for Medical Oncology (ESMO) Congress 2022 taking place September 9-13, 2022, in Paris, France.

The Menarini Group obtained global licensing rights for elacestrant in July 2020 from Radius Health, Inc, who conducted and successfully completed the EMERALD study. Based on the positive phase 3 data, Stemline submitted a MAA to EMA on July 27, 2022. The regulatory review for elacestrant is also underway in the US as the Food and Drug Administration (FDA) has recently accepted a new drug application for elacestrant designating a priority review. The Menarini Group is now fully responsible for global registration, commercialization and further development activities for 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 completed prior to EMERALD indicate that the compound has the potential for use as a single agent or in combination with other therapies for the treatment of breast cancer. The EMERALD Phase 3 trial is a randomized, open label, active-controlled study evaluating elacestrant as second- or third-line monotherapy in ER+/HER2- advanced/metastatic breast cancer patients. The study enrolled 477 patients who had received prior treatment with one or two lines of endocrine therapy, including a CDK 4/6 inhibitor. Patients in the study were randomized to receive either elacestrant or the investigator's choice of an approved hormonal agent. The primary endpoint of the study was progression-free survival (PFS) in the overall patient population and in patients with estrogen receptor 1 gene (ESR1) mutations. Secondary endpoints included evaluation of overall survival (OS), objective response rate (ORR), and duration of response (DOR) and safety.

About The Menarini Group
The Menarini Group is a leading international pharmaceutical and diagnostics company, with a turnover of over $4 billion and over 17,000 employees. Menarini is focused on therapeutic areas with high unmet needs with products for cardiology, oncology, pneumology, gastroenterology, infectious diseases, diabetology, inflammation, and analgesia. With 18 production sites and 9 Research and Development centers, Menarini's products are available in 140 countries worldwide. For further information, please visit www.menarini.com

About Stemline
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 a novel targeted treatment directed to CD123 for patients with blastic plasmacytoid dendritic cell neoplasm (BPDCN) in the United States and Europe which is also being evaluated as monotherapy and in combination with other agents, in additional clinical trials for a variety of other indications. Stemline has an extensive clinical pipeline of small molecules and biologics in various stages of development for a host of solid and hematologic cancers. 

About Radius
Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health, neuro-orphan diseases, and oncology. Radius' lead product, TYMLOS® (abaloparatide) injection, was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

Logo - https://mma.prnewswire.com/media/652491/MENARINI_Group_Logo.jpg

 

 

SOURCE Menarini Industrie Farmaceutiche Riunite


These press releases may also interest you

at 07:00
Palantir Technologies Inc. today announced that it was selected by the Defense Information Systems Agency (DISA) to deliver an Electromagnetic Battle Management - Joint Decision Support (EMBM-J DS) Prototype. This effort will provide the Department...

at 06:30
The Actuators market is estimated at USD 67.7 billion in 2024 and is projected to reach USD 94.8 billion by 2029, at a CAGR of 7.0 % from 2024 to 2029 according to a new report by MarketsandMarketstm. The growth can be attributed to growing...

at 06:13
JinkoSolar Holding Co., Ltd. ("JinkoSolar" or the "Company") , one of the largest and most innovative solar module manufacturers in the world, today announced that since March 20, 2024, the Company has repurchased 788,178 American depositary shares...

at 06:05
AIS Healthcare, a leading provider of targeted drug delivery (TDD) and infusion care solutions, is proud to recognize March 25-31 as National Physicians Week. This week and throughout the year, we celebrate the dedication of physicians who selflessly...

at 06:02
With thousands of press releases published each week, it can be difficult to keep up with everything on PR Newswire. To help journalists and consumers stay on top of the week's most newsworthy and popular releases, here's a recap of some major...

at 06:00
G-P (Globalization Partners), the recognized leader in the global employment market, and standard bearer for industry compliance, today announced it was awarded 50 leader badges in G2's 2024 Spring Report, including Employer of Record Leader, Global...



News published on and distributed by: