Menarini Reports EMA's Validation of MAA for Elacestrant to Treat ER+/HER2- Advanced or Metastatic Breast Cancer
Shots:
- The EMA has validated the MAA for elacestrant for ER+/HER2- advanced or metastatic breast cancer
- The submission was based on the P-III (EMERALD) study to evaluate elacestrant vs SOC endocrine monothx. in 477 patients with ER+/HER2- advanced or metastatic breast cancer who had received prior treatment with one or two lines of endocrine therapy, incl. a CDK 4/6 inhibitor which showed a significant difference in the efficacy for both the overall study population & whose tumors harbor an ESR1 mutation
- With the validation, the submission is complete & the EMA will now initiate the review procedure. If Elacestrant is approved, it will be the 1st oral SERD to be available for 2L & 3L ER+/HER2- advanced or metastatic breast cancer in the EU
Ref: Buisnesswire | Image: Menarini
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