China-based Jiangsu Hengrui Medicine Co., Ltd (SHA: 600276) has announced that its supplementary market filing for its tyrosine kinase inhibitor (TKI) pyrotinib has been accepted for review by the National Medical Products Administration (NMPA). The targeted indication is for use in combination with trastuzumab plus docetaxel in advanced, recurrent or metastatic breast cancer that is human epidermal growth factor receptor 2 (HER2) positive in patients not previously treated with anti-HER2 therapies.
Pyrotinib: Drug Profile and Development
Pyrotinib is an in-house developed Category 1.1 EGFR/HER2 inhibitor. The drug was included in the National Reimbursement Drug List (NRDL) in 2019 and won conditional market approval in China in August 2018. It received full market approval for use in HER2-positive advanced or metastatic previously treated breast cancer in combination with capecitabine in July 2020.
Clinical Study Results
The filing is based on the randomized, double-blind, parallel controlled, multi-center Phase III HR-BLTN-III-MBC-C study for pyrotinib combined with trastuzumab plus docetaxel as a first-line treatment for HER2-positive recurrent/metastatic breast cancer. The study reached its primary endpoint in August of this year, demonstrating that the combination significantly prolonged progression-free survival (PFS) in patients with HER2-positive breast cancer who had not previously received any systemic anti-tumor therapy.
Future Outlook
The acceptance of the supplementary market filing for pyrotinib by the NMPA underscores Hengrui Medicine’s commitment to advancing innovative treatments for HER2-positive breast cancer. By expanding its indications, Hengrui aims to improve patient outcomes and address significant unmet medical needs in oncology.-Fineline Info & Tech
