"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."