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CHMP Recommends Menarini's Orserdu for ESR1-Mutated Advanced Breast Cancer Patients

NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use on Friday recommended the Menarini Group's selective estrogen receptor degrader Orserdu (elacestrant) for patients in Europe with previously treated advanced breast cancer that is estrogen receptor positive and HER2 negative and harbors ESR1 mutations. 

The committee recommended that Orserdu, which is a product of Menarini's subsidiary Stemline Therapeutics, be approved as a monotherapy for patients whose cancers progress after at least one line of endocrine therapy including a CDK 4/6 inhibitor. 

CHMP based its positive recommendation on the results of the randomized Phase III EMERALD trial, in which breast cancer patients with ESR1 mutations benefited more from Orserdu than standard-of-care treatment with an investigator's choice of endocrine therapy. Patients given Orserdu lived for a median of 3.8 months without their cancers progressing versus 1.9 months among those treated with standard of care. 

The US Food and Drug Administration approved Orserdu as a treatment for this patient population in January 2023, at which time it also approved Guardant Health's Guardant360 CDx as a blood-based assay to identify patients with ESR1 mutations eligible for the therapy.