As part of the submission, the companies have also requested priority review with the FDA for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer.
Radius Health Inc and The Menarini Group have submitted a new drug application (NDA) to the FDA for elacestrant in individuals with estrogen receptor-positive (ER+)/human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer.
As part of the submission, the companies have also requested priority review with the FDA. If granted, the companies anticipate an 8-month review, incorporating a 6-month priority designation review.
“Elacestrant has shown statistically significant efficacy over current standard of care medications both for overall population and in patients whose tumors harbor an [estrogen receptor 1] mutation, one of the most difficult to treat mechanisms of acquired resistance that develops in the later stages of metastatic/advanced breast cancer,” Elcin Barker Ergu, CEO of Menarini, said in a statement.
The NDA submission is based on positive phase 3 data from the EMERALD study that were previously announced on October 20, 2021. EMERALD med both its primary endpoints, which were progression-free survival (PFS) in the overall population and PFS in the ESR1 mutation subgroup compared to the standard of care with the option of fulvestrant or an aromatase inhibitor.
“We enrolled and completed the EMERALD trial in a high-quality manner, delivered positive topline results, and prepared the submission of the NDA to the FDA. The submission is a significant milestone for both companies, and we appreciate the strong, collaborative effort of many hard-working employees at Radius and Menarini, investigators, patients, and their families. Together we look forward to advancing elacestrant and providing the opportunity to benefit patients,” Chhaya Shah, SVP of Clinical and Regulatory at Radius, said in a statement.
EMERALD evaluated elacestrant as second- or third-line monotherapy in ER+/HER2- advanced or metastatic breast cancer. The study included 477 patients who received prior treatment with 1 or 2 lines of endocrine therapy, including CDK 4/6 inhibitor.
Investigators randomized patients to receive either elacestrant or the investigator’s choice of an approved hormonal agent.
The secondary endpoints included evaluation of overall survival, objective rate, and duration of response.
Following the completion of EMERALD, data from the study was presented at the San Antonio Breast Cancer Symposium on December 8, 2021, published in the Journal of Clinical Oncology, on May 18, 2022, and further subset analyses were presented at the 2022 American Society of Clinical Oncology Annual Meeting on June 6, 2022.
“We plan to test elacestrant in earlier treatment lines, combination trials, and metastatic breast cancer that has metastasized to the brain. These details are to be communicated by us throughout 2H 2022 and 1H 2023,” Nassir Habboubi, global head of Pharma R&D of Menarini Group, said in a statement.
With the submission of the NDA, Menarini takes over activities and will be responsible for registration and commercialization. Menarini plans to use its fully owned subsidiary in the United States, Stemline Therapeutics, to commercialize elacestrant if approved by the FDA, the company announced in a press release.
Elacestrant is the first and currently only 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, according to Radius Health Inc and The Menarini Group.
Menarini Group and Radius Health submit new drug application to the US FDA for elacestrant. Radius. News release. June 22, 2022. Accessed June 28, 2022. https://ir.radiuspharm.com/news-releases/news-release-details/menarini-group-and-radius-health-submit-new-drug-application-us