FDA Assigns Priority Review for Elacestrant in Metastatic Breast Cancer

The FDA has accepted the Menarini’s new drug application (NDA) for elacestrant to treat patients with ER+/HER2- advanced or metastatic breast cancer. The FDA has granted the application priority review and assigned a PDUFA date of Feb. 17, 2023. The NDA was submitted in June 2022.

The NDA submission was supported by results of the phase 3 data from the EMERALD study. The clinical trial data showed that elacestrant reduced the risk of disease progression or death by 30% in all patients and by 45% in patients with ESR1 mutation. The data also showed a manageable safety profile.

EMERALD met both of its primary endpoints of progression-free survival (PFS) in the overall population and in patients with the ESR1 mutation (mESR1) compared with standard of care endocrine monotherapy; the trial’s comparator arms were investigators’ choice of either fulvestrant or an aromatase inhibitor. The PFS rate at 12 months with elacestrant was 22.32% vs. 9.42% with standard of care in the overall population, and 26.76% vs. 8.19% in the ESR1 mutation population.

Menarini obtained global licensing rights for elacestrant in July 2020 from Radius Health, which conducted the EMERALD study.

Elacestrant is a selective estrogen receptor degrader (SERD), type of drug that down regulates the estrogen receptor. SERD and full receptor antagonists are essential treatment options for HR-positive breast cancer, especially in patients who have been become resistant to tamoxifen or aromatase inhibitors.

AstraZeneca’s Faslodex (fulvestrant) was the first SERD to be approved by the FDA in 2002. It is an injection therapy for patients with estrogen receptor positive breast cancer. A first generic version of Faslodex was launched by Sandoz in 2019.