EMA validates Menarini's application for breast cancer SERD elacestrant

Today, privately-held Italian pharmaceutical and diagnostics company Menarini, and wholly-owned US subsidiary Stemline Therapeutics, announced the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for elacestrant, an investigational oral selective estrogen receptor degrader (SERD) for patients with ER+/HER2- advanced or metastatic breast cancer.

This comes on the back of last week’s news from the companies that the US Food and Drug Administration (FDA) has accepted their New Drug Application (NDA) for elacestrant. European approval is anticipated for the second half of 2023.

The Phase III data from the EMERALD study that supported the EMA submission is complete and begins the EMA’s centralized review procedure. The study met both of its pre-specified primary endpoints of progression-free survival (PFS) in the overall population and in patients with the ESR1 mutation compared to the standard of care, endocrine monotherapy. 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 mutations. The data also showed a manageable safety profile.