Menarini and Radius file NDA with FDA for elacestrant

Family-owned Italian drugmaker Menarini Group and USA-based Radius Health (Nasdaq: RDUS) have announced that Menarini, with support from Radius, has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) 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 six-month priority designation review.

The NDA submission is based on positive Phase III data from the EMERALD study that was previously announced on October 20, 2021. EMERALD met both of its primary endpoints, which were progression-free survival (PFS) in the overall population and PFS in the estrogen receptor 1 (ESR1) mutation subgroup as compared to standard of care (SoC) with the options of fulvestrant or an aromatase inhibitor.