Menarini Submits NDA To FDA For Elacestrant

(RTTNews) - Menarini Group and Radius Health Inc. (RDUS) said that Menarini, with support from Radius, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer.

As part of the submission, the Companies have requested Priority Review with the FDA. If Priority Review is granted, the Companies anticipate that the FDA would conduct an 8-month review, incorporating a 6-month priority designation review.

The NDA submission is based on positive phase 3 data from the EMERALD study that was previously announced on October 20, 2021.

Elacestrant is the investigational oral SERD to show positive topline results in a pivotal trial for the treatment of ER+/HER2- advanced or metastatic breast cancer in postmenopausal women, and men.

Menarini Group said the companies plan to test elacestrant in earlier treatment lines, combination trials, and metastatic breast cancer that has metastasized to the brain. The details are to be communicated by them throughout second-half of 2022 and the first half of 2023.