(Finance) – The Committee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency (EMA) gave a positive opinion for elastic (ORSERDU®) indicated for the treatment of a type of advanced or metastatic breast cancer. Elacestrant (ORSERDU®) was approved last January by Food and Drug Administration (FDA) Priority Review and Fast Track based on results from the pivotal Phase III study EMERALD.
It is a degrader selective receptor inhibitor (SERD) for the treatment of postmenopausal women and adult men with estrogen receptor positive (ER+) and HER2- receptor negative (ER+) advanced or metastatic breast cancer who have developed ESR1 mutations after at least one line of endocrine therapy.
It is the first and only SERD to oral administrationand to have successfully completed the last step of clinical development (phase III), to have been approved by the FDA and to have received a positive opinion from the CHMP. The drug is available today in the United States via Menarini Stemlinesa biopharmaceutical company acquired by the Menarini Group in 2020.