Menarini Group and Stemline Therapeutics Receive EC’s Approval for Orserdu (elacestrant) to Treat ER+, HER2- Locally Advanced or Metastatic Breast Cancer
Shots:
- The EC has approved Orserdu as a monotx. for postmenopausal women & men, with ER+, HER2-, LA or mBC with an activating ESR1 mutation who have disease progression following one line of endocrine therapy incl. a CDK 4/6 inhibitor
- The approval was based on the P-III trial (EMERALD) 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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