Menarini's elacestrant accepted for priority review by the US FDA

Privately held Italian pharmaceutical and diagnostics company Menarini, and wholly-owned US subsidiary Stemline Therapeutics, yesterday announced that the US Food and Drug Administration (FDA) has accepted their 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.

“The FDA’s acceptance of our NDA with Priority Review marks an important regulatory milestone for our company,” commented Elcin Barker Ergun, chief executive of the Menarini Group. “We look forward to working with the FDA during its review of this submission, which addresses a new potential therapeutic option for a major unmet need in the management of patients with advanced or metastatic breast cancer after resistance builds in the earlier lines of the treatment,” she added.