{"id":47469,"date":"2022-08-19T11:02:14","date_gmt":"2022-08-19T09:02:14","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/menarini-groups-elacestrant-marketing-authorization-application-accepted-for-review-by-the-european-medicines-agency-ema-for-the-treatment-of-er-her2-advanced-or-metastatic-breast-cancer\/"},"modified":"2022-08-19T11:02:14","modified_gmt":"2022-08-19T09:02:14","slug":"menarini-groups-elacestrant-marketing-authorization-application-accepted-for-review-by-the-european-medicines-agency-ema-for-the-treatment-of-er-her2-advanced-or-metastatic-breast-cancer","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/menarini-groups-elacestrant-marketing-authorization-application-accepted-for-review-by-the-european-medicines-agency-ema-for-the-treatment-of-er-her2-advanced-or-metastatic-breast-cancer\/","title":{"rendered":"Menarini Group\u2019s Elacestrant Marketing Authorization Application Accepted for Review by the European Medicines Agency (EMA) for the Treatment of ER+\/HER2- Advanced or Metastatic Breast Cancer"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\n<i>Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for<\/i> <i>patients suffering from second-line (2L) and third-line (3L) ER+\/HER2- advanced or metastatic breast cancer in the European Union<\/i>\n<\/li>\n<li>\n<i>Submission supported by results from the pivotal Phase 3 EMERALD study showing a statistically significant difference in the efficacy in favor of elacestrant over current standard-of-care (SOC) medications for both the overall study population and patients whose tumors harbor an ESR1<\/i> <i>mutation.<\/i>\n<\/li>\n<\/ul>\n<p>FLORENCE, Italy &amp; NEW YORK&#8211;(BUSINESS WIRE)&#8211;<a href=\"https:\/\/twitter.com\/hashtag\/BreastCancer?src=hash\" target=\"_blank\" rel=\"noopener\">#BreastCancer<\/a>&#8211;The Menarini Group (\u201cMenarini\u201d), a privately held Italian pharmaceutical and diagnostics company, and Stemline Therapeutics (\u201cStemline\u201d), 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\u2019s centralized review procedure.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220819005055\/en\/1548483\/5\/MENARINI_Group_Logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220819005055\/en\/1548483\/21\/MENARINI_Group_Logo.jpg\"><\/a><\/p>\n<p>\n\u201cThere 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,\u201d commented Elcin Barker Ergun, Chief Executive Officer of the Menarini Group. \u201cThe 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.\u201d\n<\/p>\n<p>\nThe Phase 3 EMERALD study (NCT03778931) evaluated elacestrant compared to SOC endocrine monotherapy (investigators\u2019 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 <i>Journal of Clinical Oncology<\/i> (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.\n<\/p>\n<p>\nThe 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 U.S. 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.\n<\/p>\n<p>\n<b>About Elacestrant (RAD1901) and the EMERALD Phase 3 Study<br \/>\n<br \/><\/b>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\u2019s 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 (<i>ESR1<\/i>) mutations. Secondary endpoints included evaluation of overall survival (OS), objective response rate (ORR), and duration of response (DOR) and safety.\n<\/p>\n<p>\n<b>About The Menarini Group<br \/>\n<br \/><\/b>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\u2019s products are available in 140 countries worldwide. For further information, please visit <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.menarini.com&amp;esheet=52819674&amp;newsitemid=20220819005055&amp;lan=en-US&amp;anchor=www.menarini.com&amp;index=1&amp;md5=850ef437b9169d87c1553a3a64b3f6ed\" rel=\"nofollow noopener\" shape=\"rect\">www.menarini.com<\/a>.\n<\/p>\n<p>\n<b>About Stemline<br \/>\n<br \/><\/b>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.\n<\/p>\n<p>\n<b>About Radius<br \/>\n<br \/><\/b>Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health, neuro-orphan diseases, and oncology. Radius\u2019 lead product, TYMLOS\u00ae (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.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\n<b>Media Relations:<\/b><br \/>The Menarini Group<br \/>\n<br \/>Valeria Speroni Cardi<br \/>\n<br \/><a target=\"_blank\" href=\"mailto:pressoffice&#64;menar&#105;&#110;&#105;&#46;&#99;&#111;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#x70;&#114;&#101;s&#x73;&#x6f;&#102;f&#x69;&#x63;&#101;&#64;&#x6d;&#x65;&#110;a&#x72;&#x69;&#110;i&#x2e;&#x63;&#111;m<\/a>\n<\/p>\n<p>\n<b>U.S. Media<\/b><br \/>Shani Lewis<br \/>\n<br \/>LaVoieHealthScience<br \/>\n<br \/>+1 609 516 5761<br \/>\n<br \/><a target=\"_blank\" href=\"m&#97;&#105;&#108;&#x74;&#x6f;&#x3a;sl&#101;&#119;&#x69;&#x73;&#x40;&#x6c;av&#111;&#105;&#x65;&#x68;&#x65;&#x61;l&#116;&#104;&#115;&#x63;&#x69;&#x65;nc&#101;&#46;&#99;&#x6f;&#x6d;\" rel=\"nofollow noopener\" shape=\"rect\">&#x73;&#x6c;&#x65;&#x77;&#105;&#115;&#64;&#108;avo&#x69;&#x65;&#x68;&#x65;&#x61;&#108;&#116;&#104;sci&#x65;&#x6e;&#x63;&#x65;&#x2e;&#99;&#111;&#109;<\/a>\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+\/HER2- advanced or metastatic breast cancer in the European Union Submission supported by results from the pivotal Phase 3 EMERALD study showing a statistically significant difference in the efficacy in &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/menarini-groups-elacestrant-marketing-authorization-application-accepted-for-review-by-the-european-medicines-agency-ema-for-the-treatment-of-er-her2-advanced-or-metastatic-breast-cancer\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-47469","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Menarini Group\u2019s Elacestrant Marketing Authorization Application Accepted for Review by the European Medicines Agency (EMA) for the Treatment of ER+\/HER2- Advanced or Metastatic Breast Cancer - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/menarini-groups-elacestrant-marketing-authorization-application-accepted-for-review-by-the-european-medicines-agency-ema-for-the-treatment-of-er-her2-advanced-or-metastatic-breast-cancer\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Menarini Group\u2019s Elacestrant Marketing Authorization Application Accepted for Review by the European Medicines Agency (EMA) for the Treatment of ER+\/HER2- Advanced or Metastatic Breast Cancer - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from second-line (2L) and third-line (3L) ER+\/HER2- advanced or metastatic breast cancer in the European Union Submission supported by results from the pivotal Phase 3 EMERALD study showing a statistically significant difference in the efficacy in ... 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