Posted by Michael Wonder on 21 Sep 2023
European Commission approves Menarini Group’s Orserdu (elacestrant) for the treatment of patients with ER+, HER2- locally advanced or metastatic breast cancer with an activating ESR1 mutation
20 September 2023 - Orserdu is the first treatment specifically for patients with oestrogen receptor positive, HER2 negative advanced or metastatic breast cancer tumours that harbour ESR1 mutations, representing the first innovation in endocrine therapy in nearly 20 years.
The Menarini Group and Stemline Therapeutics announced today that the European Commission has approved Orserdu (elacestrant) as a monotherapy for the treatment of post-menopausal 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.
