FDA Accepts Menarini Group and Radius Health's Filing Under Priority Review For Breast Cancer Candidate

The U.S. Food and Drug Administration (FDA) has accepted the Menarini Group and Radius Health’s RDUS New Drug Application (NDA) for the lead asset elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer.

The agency has granted Priority Review designation and assigned a target action date of February 17, 2023.

The New Drug Application (NDA) submission was supported by results of the Phase 3 data readout from the EMERALD study that met both of its pre-specified primary endpoints of progression-free survival (PFS) in the overall population.

Elacestrant, an investigational selective estrogen receptor degrader (SERD) and is not approved by any regulatory authorities. Previously, FDA granted Fast Track designation for elacestrant.

Elcin Barker Ergun, Chief Executive Officer of the Menarini Group, commented: ”The FDA's acceptance of our NDA with Priority Review marks an important regulatory milestone for our company.  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.”

The Menarini Group obtained global licensing rights for elacestrant in July 2020 from Radius Health, that conducted and successfully completed the EMERALD study.

The FDA grants Priority Review that shortens review period of NDA, applicable for medicines which may offer significant improvements in the treatment, diagnosis, or prevention of a serious condition.

Price Action : Radius Health shares are trading around 1 percent higher at $10.15 on Thursday during pre-market session.