Policy & Regulation
The Menarini Group and Radius Health complete FDA New Drug Application submission for elacestrant
23 June 2022 -

The Menarini Group, an Italy-based international pharmaceutical and diagnostics company, and United States-based Radius Health, Inc. (NASDAQ: RDUS) announced on Wednesday that the companies have submitted a New Drug Application (NDA) to the United States Food and Drug Administration (FDA) for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer.

Under the submission, the companies have asked for Priority Review with the FDA. If Priority Review is granted, the firms expect that the FDA is to carry out an eight-month review, incorporating a six-month priority designation review. The NDA submission is based on positive phase three data from the EMERALD study.

The product is claimed to be the first and presently the only investigational oral SERD to indicate positive topline results in a pivotal trial for the treatment of ER+/HER2- advanced or metastatic breast cancer in postmenopausal women, and men. These outcomes indicated that the product is also active in patients whose tumours harbour an ESR1 mutation.