
Menarini Submits NDA Elacestrant for Advanced Breast Cancer
Elacestrant is oral therapy that targets estrogen receptor 1, a key resistance mechanism in advanced breast cancer.
Menarini Group and Radius Health have
If approved, elacestrant it would be the first oral therapy in a class of medications called selective estrogen receptor degraders (SERDs), which binds to the estrogen receptor and causes it to be downregulated. As a result, SERDs are being
AstraZeneca’s Faslodex (fulvestrant) was the first SERD to be approved by the FDA in 2017. It is an injection therapy for patients with estrogen receptor positive breast cancer.
“We are excited about the potential for elacestrant to be approved for treatment of patients with advanced or metastatic ER+/HER2- breast cancer, which constitutes about 70% of breast cancer and remains an area of significant unmet medical need,” Elcin Barker Ergun, the chief executive dfficer of Menarini, said in a press release.
The elacestrant submission is based on positive phase 3 data from the EMERALD study, which showed that elacestrant met both of its primary endpoints, which were progression-free survival in the overall population and progression-free survival in the estrogen receptor 1 (ESR1) mutation subgroup compared with standard of care with the options of (Faslodex) fulvestrant or an aromatase inhibitor.
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