China-based Luye Pharma Group (HKG: 2186) announced that another market filing for its goserelin acetate sustained-release injectable microspheres (LY01005) as a treatment for breast cancer has been accepted for review by China’s Center for Drug Evaluation (CDE). The drug is already under review for its use in treating prostate cancer.
Drug Details
LY01005 is a microsphere preparation of goserelin acetate, a gonadotropin-releasing hormone agonist. It is designed for monthly intramuscular injection to treat prostate cancer, breast cancer, and endometriosis, among other conditions. The drug effectively reduces adverse reactions at the injection site, improves the patient’s medication experience, eases nursing difficulties, and enhances patient tolerance and compliance.
Clinical Study Results
The filing for breast cancer is based on positive results from a Phase III clinical study. The study showed that LY01005, administered intramuscularly at a dose of 3.6 mg every 28 days, effectively controlled serum estradiol levels in breast cancer patients to postmenopausal levels. The clinical efficacy was comparable to the control drug, and the safety profile was similar, with no injection site adverse reactions. Patient compliance was increased, indicating a good overall safety and tolerability profile.-Fineline Info & Tech
