FDA accepts NDA for elacestrant to treat patients with ER+/HER2- advanced or metastatic breast cancer
The Menarini Group announced that the FDA has accepted the Company’s New Drug Application (NDA) for elacestrant, an investigational selective estrogen receptor degrader (SERD), for patients with ER+/HER2- advanced or metastatic breast cancer
The FDA has granted the application Priority Review and assigned a PDUFA date of February 17, 2023.
Dr. Aditya Bardia, MD, breast medical oncologist at Mass General Cancer Center, Harvard Medical School and principal investigator of EMERALD, commented, “Patients with pre-treated ER+/HER2- advanced or metastatic breast cancer currently have limited treatment options due to the development of endocrine therapy resistance from earlier treatment lines.” Dr. Bardia continued, “Elacestrant – as the first oral SERD – has the potential to become the new standard of care given its performance vs. intramuscular fulvestrant and SoC in the overall population and in the ESR1 patient subgroup. As an oral monotherapy, elacestrant will offer patients, their families, and healthcare providers an efficacious and safe treatment option going forward.”
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