China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced a supplementary market filing for its CDK 4/6 inhibitor, dalpiciclib (SHR6390), 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. The filing has been accepted for review by the National Medical Products Administration (NMPA).
Clinical Study and Filing Basis
The filing is based on the results of the multi-center, randomized, placebo-controlled, double-blind Phase III DAWNA-2 study. The study demonstrated that dalpiciclib, when combined with an aromatase inhibitor as the initial treatment, significantly extended progression-free survival (PFS) in patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer. These results highlight the potential of dalpiciclib to improve outcomes for patients with this challenging form of breast cancer.
Dalpiciclib: First Domestic 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. Similar products currently marketed in China include Pfizer’s Ibrance (palbociclib) and Eli Lilly’s Verzenio (abemaciclib), the latter of which entered the National Reimbursement Drug List (NRDL) in December 2021.
Future Outlook
The supplementary market filing for dalpiciclib underscores Hengrui Medicine’s commitment to expanding the therapeutic options available for patients with HR-positive, HER2-negative breast cancer. If approved, dalpiciclib could offer a new first-line treatment option, potentially improving patient outcomes and further solidifying Hengrui’s position in the oncology market.-Fineline Info & Tech
