19 August 2022 - - The EMA has validated the Marketing Authorization Application for elacestrant, a selective estrogen receptor degrader, for patients with ER+/HER2- advanced or metastatic breast cancer, Italy-based pharmaceutical and diagnostics company The Menarini Group and its Stemline Therapeutics subsidiary said.

Validation of the application confirms the submission is complete and begins EMA's centralized review procedure.

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 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 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.

Elacestrant is an investigational selective estrogen receptor degrader. 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 in the overall patient population and in patients with estrogen receptor 1 gene mutations. Secondary endpoints included evaluation of overall survival, objective response rate, and duration of response and safety.

The Menarini Group is a international pharmaceutical and diagnostics company, with a turnover of over USD 4bn 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 nine Research and Development centers, Menarini's products are available in 140 countries worldwide.

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.

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 US Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture.