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
With this approval, ORSERDU is the first and only therapy specifically indicated for the treatment of ER+, HER2- tumors that harbor ESR1 mutations.
- With this approval, ORSERDU is the first and only therapy specifically indicated for the treatment of ER+, HER2- tumors that harbor ESR1 mutations.
- ESR1 mutations are acquired mutations that develop as a result of exposure to endocrine therapy, and they are found in up to 40% of patients with ER+, HER2- mBC.
- ESR1 mutations are a known driver of resistance to standard endocrine therapy, and until now, the tumors that harbor these mutations have been more difficult to treat.
- The primary endpoints of the study were PFS in the overall patient population and in patients with ESR1 mutations.