As part of the filing, the companies also requested a priority review from the FDA for elatran in patients with ER+/HER2 advanced or metastatic breast cancer.
Radius Health Inc and The Menarini Group have filed a new drug application (NDA) with the FDA for elatran in subjects with estrogen receptor positive (ER+)/human epidermal growth factor receptor 2 negative (HER2) advanced or metastatic breast cancer.
As part of the filing, the companies also requested a priority review from the FDA. If granted, the companies expect an 8-month evaluation, including a 6-month priority designation evaluation.
“Elacestrant has demonstrated statistically significant efficacy over current standard medications, both for the overall population and in patients whose tumors have a [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,” Menarini CEO Elcin Barker Ergu said in a statement.
The NDA submission is based on positive Phase 3 data from the EMERALD trial previously announced on October 20, 2021. EMERALD mediated both primary endpoints, namely progression-free survival (PFS) in the overall population and PFS in the ESR1 mutation subgroup compared to standard treatment with the choice of fulvestrant or an aromatase inhibitor.
“We successfully enrolled and completed the EMERALD trial, delivered positive topline results, and prepared the NDA submission to the FDA. The filing is an important milestone for both companies and we appreciate the strong, collaborative effort of many hard-working Radius and Menarini employees, researchers, patients and their families. Together, we look forward to advancing elamestrant and providing the opportunity to help patients,” Chhaya Shah, SVP of Clinical and Regulatory at Radius, said in a statement.
EMERALD evaluated elatran as second or third line monotherapy in ER+/HER2 advanced or metastatic breast cancer. The study included 477 patients who had previously been treated with 1 or 2 lines of endocrine therapy, including CDK 4/6 inhibitor.
Investigators randomized patients to receive either elatran or, at the investigator’s discretion, 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 were presented at the San Antonio Breast Cancer Symposium on December 8, 2021, published in the Journal of Clinical Oncologyon May 18, 2022, and further subset analyzes were presented at the 2022 American Society of Clinical Oncology Annual Meeting on June 6, 2022.
“We plan to test elatran in previous lines of treatment, combination trials and metastatic breast cancer that has spread to the brain. These details will be communicated by us during 2H 2022 and 1H 2023,” said Nassir Habboubi, global head of Pharma R&D at Menarini Group, in a statement.
With the submission of the NDA, Menarini takes over the business and becomes responsible for registration and commercialization. Menarini plans to use its wholly owned subsidiary in the United States, Stemline Therapeutics, to commercialize elatran, if approved by the FDA, the company announced in a press release.
According to Radius Health Inc and The Menarini Group, Elacestrant is the first and currently only oral SRD under investigation 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 and Radius Health file a new drug application with the US FDA for elatran. Ray. news item. 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