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# Menarini/Radius Submit Breast Cancer NDA
- URL: https://www.fdaweb.com/menarini-radius-submit-breast-cancer-nda/
- Published: 2022-08-11T12:00:00.000Z
- Updated: 2026-09-14T17:55:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152492

Italy’s Menarini Group, with support from Radius Health, has submitted an NDA to FDA for elacestrant in patients with ER+/HER2- advanced breast cancer. An [announcement](https://ir.radiuspharm.com/news-releases/news-release-details/menarini-group-and-radius-health-submit-new-drug-application-us?ref=fdaweb.com) says the companies requested a priority review.

The companies say the submission is based on positive Phase 3 data from the EMERALD study that met both of its primary endpoints — progression-free survival in the overall population and the estrogen receptor 1 mutation subgroup as compared to standard of care with the option of fulvestrant or an aromatase inhibitor.

Elacestrant is described as an investigational selective estrogen receptor degrader that is being evaluated for potential use as a once-daily oral treatment in patients with ER+/HER2- advanced breast cancer. It received a fast track designation from FDA in 2018.