Privately-held Italian drugmaker Menarini has announced results from a new analysis of the pivotal EMERALD clinical study that suggest that oral single-agent Orserdu (elacestrant) may be effective in ER+, HER2- advanced or metastatic breast cancer patients with non-detected ESR1-mut whose disease has progressed within six months of treatment with a CDK4/6i.
Menarini’s wholly-owned subsidiary Stemline Therapeutics gained US Food and Drug Administration (FDA) approval of Orserdu, an oral selective estrogen receptor degrader (SERD), in January this year, for postmenopausal women or adult men with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer.
Results from this new post-hoc subgroup analysis will be presented at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, USA.
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