Jiangsu Hengrui Pharmaceuticals Co., Ltd (SHA: 600276), a leading pharmaceutical company based in China, has announced receiving another indication approval for its drug dalpiciclib (SHR6390). The approval is for use as an initial therapy combined with an aromatase inhibitor for patients with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative, locally advanced or metastatic breast cancer.
Phase III Study Results and Approval Basis
The approval is supported by the results of a multi-center, randomized, controlled, double-blind Phase III study. The study demonstrated that in patients with HR positive, HER2 negative local advanced or metastatic breast cancer, dalpiciclib combined with an aromatase inhibitor as the initial treatment significantly extended the median progression-free survival (mPFS) from 18.2 months to 30.6 months, reduced the risk of disease progression or death by 49%, and maintained good safety.
Dalpiciclib: China’s First Domestically-Developed CDK 4/6 Inhibitor
Dalpiciclib is China’s first domestically-developed cyclin-dependent kinase 4 and 6 (CDK 4/6) inhibitor. It obtained market approval in China in December 2021 with priority review status for use in HR-positive and HER2-negative recurrent or metastatic breast cancer that has progressed after endocrine therapy, combined with fulvestrant. The drug is currently undergoing the SHR6390-III-303 study, which is assessing the efficacy and safety of the drug combined with endocrine therapy as adjuvant therapy for 4350 cases of early high-risk HR+/HER2 breast cancer.-Fineline Info & Tech
