Menarini Group and Stemline Therapeutics Receive EMA’s CHMP Positive Opinion of Orserdu (elacestrant) for ER+, HER2- Locally Advanced or Metastatic Breast Cancer
Shots:
- The EMA’s CHMP has adopted a positive opinion on the approval of Orserdu for postmenopausal women & men with ER+ HER2- LA or metastatic breast cancer with an activating ESR1 mutation who have disease progression following one line of endocrine therapy
- The opinion was based on the P-III (EMERALD) trial results evaluating elacestrant as monotx. vs SoC in 478 patients which showed a significant PFS, m-PFS (3.8 vs 1.9mos.) in the group of patients whose tumors had ESR1 mutations, 45% reduction in risk of progression or death
- In a post hoc subgroup analysis, the duration of prior CDK4/6i treatment was associated with longer PFS on elacestrant, m-PFS (8.6 vs 1.9mos.) for patients with ESR1 mutations treated with CDK4/6i for ≥12mos., 59% reduction in risk of progression or death
Ref: PR Newswire | Image: Menarini
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