Menarini snags priority review for SERD breast cancer med

Aug. 11, 2022

Menarini Group and its subsidiary Stemline Therapeutics announced that the U.S. FDA has accepted its NDA submission for elacestrant, an investigational selective estrogen receptor degrader (SERD) for patients with metastatic breast cancer — and granted the drug Priority Review.

Elacestrant, if approved, would be the first oral SERD to be available for patients suffering from 2L and 3L ER+/HER2- advanced or metastatic breast cancer.

The NDA submission was supported by phase 3 data from the EMERALD study. EMERALD met both of its pre-specified primary endpoints of progression-free survival in the overall population and patients with the ESR1 mutation (mESR1) compared to SOC endocrine monotherapy.

The Italian pharma group bought the global licensing rights for elacestrant, which at the time was in phase 3 studies, back in July 2020 from Radius Health.

The FDA has assigned elacestrant a PDUFA date of February 17, 2023.