Posted by Michael Wonder on 22 Jul 2023
Menarini Group receives positive CHMP opinion recommending EC approval of Orserdu (elacestrant) for the treatment of patients with ER+, HER2- locally advanced or metastatic breast cancer with an activating ESR1 mutation
21 July 2023 - If approved by the European Commission, Orserdu would be the first and only treatment specifically indicated for patients with ER+, HER2- advanced or metastatic breast cancer tumours that harbour ESR1 mutations.
The Menarini Group announced today that the CHMP of the EMA has adopted a positive opinion on the approval of Orserdu (elacestrant) monotherapy, indicated for the treatment of postmenopausal women, and men, with oestrogen receptor positive, HER2 negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.
