Elcin Barker Ergun is the chief executive officer of the Menarini Group, an Italian pharmaceutical company.
The Menarini Group and Stemline Therapeutics recently announced that the European Medicines Agency (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; a PR Newswire press release said. Validation of the application means the submission is complete and begins EMA's centralized review procedure.
The new advancement deals with an unmet need in the industry.
"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," Ergun said in the release. "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, as compared to SOC endocrine monotherapy, the release said. The Journal of Clinical Oncology (JCO) released results of the study in May, and those results will be shown to the public on Sept. 9-13 in Paris at the European Society for Medical Oncology (ESMO) Congress 2022.