SciClone Pharmaceuticals Inc. (HKG: 6600) has announced that its Italian partner, Menarini Group, has submitted a pre-licensing application for the import of Orserdu (elacestrant) in Macau, seeking approval for its use in treating advanced or metastatic breast cancer.
Elacestrant, a next-generation selective estrogen receptor degrader (SERD) developed by Eisai (TYO: 4523), was initially handed over to Radius Health for global development in 2006. In July 2020, Menarini secured exclusive global commercialization rights to the drug through a licensing agreement with Radius Health. The drug received approval in the United States and Europe in January and September 2023, respectively, for the treatment of ER+, HER2- advanced or metastatic breast cancer with ESR1 mutations.
The Macau application is supported by positive results from the Phase III EMERALD study, which demonstrated that elacestrant significantly improves progression-free survival (PFS) compared to standard endocrine monotherapy. In patients with breast cancer associated with ESR1 mutations, elacestrant reduced the risk of disease progression or death by 45%, with a PFS hazard ratio of 0.55 (95% CI: 0.39, 0.77).- Flcube.com
