The Menarini Group and its subsidiary, Stemline Therapeutics Inc., have received a favorable opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) regarding the approval of ORSERDU (elacestrant) monotherapy.

This treatment is intended for postmenopausal women and men with estrogen receptor (ER)-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have seen disease progression after at least one line of endocrine therapy, including a CDK 4/6 inhibitor. The European Commission will review the CHMP opinion, which if approved, would make ORSERDU the first and only therapy specifically indicated for ER+, HER2- tumors that harbor ESR1 mutations.

Elcin Barker Ergun, CEO of the Menarini Group, said, “Patients living with metastatic breast cancer are in need of efficacious and tolerable treatment options. ORSERDU may become the first product, if approved by the European Commission, indicated in ER+, HER2- advanced breast cancer with ESR1 mutations, which are a strong driver of resistance to treatment in up to 40% of patients in second line mBC. ORSERDU, if approved, will also provide a convenient daily oral treatment.”

The CHMP’s positive opinion of ORSERDU is backed by data from the Phase 3 EMERALD trial, which showed significant progression-free survival (PFS) with elacestrant compared to standard-of-care (SOC). In the subgroup of patients whose tumors had ESR1 mutations, elacestrant delivered a median PFS of 3.8 months versus 1.9 months on the SOC.

Menarini Group procured the global licensing rights for elacestrant from Radius Health, Inc. in July 2020 and is now entirely responsible for its global registration, commercialization, and additional development activities.

  Breast Cancer, Committee for Medicinal Products for Human Use, elacestrant, Elcin Barker Ergun, European Commission, European Medicines Agency, Italy, Menarini Group, Metastatic breast cancer, ORSERDU, Radius Health, Stemline Therapeutics