Logo

Menarini Reports EMA's Validation of MAA for Elacestrant to Treat ER+/HER2- Advanced or Metastatic Breast Cancer

Share this

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

 

Click here to­ read the full press release 

Senior Editor

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions