FDA approves Orserdu (elacestrant) for endocrine therapy-treated postmenopausal women or adult men with ER+ve, HER2-neg, ESR1-mutated advanced or metastatic breast cancer
“The FDA approval of ORSERDU marks the first ever therapy for ER+, HER2- advanced or metastatic breast cancer patients with ESR1 mutations and we are very proud to offer a targeted therapy addressing this huge unmet need,” commented Elcin Barker Ergun, Chief Executive Officer of the Menarini Group. “We are grateful to the patients, investigators and administrators who participated in the clinical trials that led to this remarkable innovation.”
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