(Teleborsa) – The Committee for Medicinal Products for Human Use (CHMP) of theEuropean Medicines Agency (EMA) gave a positive opinion for exult (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 degradatore 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 a 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 Stemlinea biopharmaceutical company acquired by the Menarini Group in 2020.