Posted: Friday, August 12, 2022
On August 11, the Menarini Group and Stemline Therapeutics announced that the U.S. Food and Drug Administration (FDA) has accepted a new drug application for elacestrant for patients with estrogen receptor–positive/HER2-negative advanced or metastatic breast cancer. The FDA has granted Priority Review status to the application for this investigational selective estrogen receptor degrader (SERD). A Prescription Drug User Fee Act date of February 17, 2023, has been assigned by the FDA.
The application is supported by the results of the phase III data from the EMERALD study (ClinicalTrials.gov identifier NCT03778931), which met both its prespecified primary endpoints of progression-free survival in the overall population and in patients with an 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 study evaluated this SERD as second- or third-line monotherapy in 477 patients with estrogen receptor–positive/HER2-negative advanced or metastatic breast cancer who had received prior treatment with one or two lines of endocrine therapy, including a CDK4/6 inhibitor.
The progression-free survival rate at 12 months with elacestrant was 22.3% vs. 9.4% with the standard of care in the overall population and 26.8% vs. 8.2% in the ESR1-mutation population. 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 an ESR1 mutation. The data also showed a manageable safety profile.