The Center for Drug Evaluation (CDE) website indicates that China-based Hengrui Medicine Co., Ltd’s (SHA: 600276) pyrotinib has been granted breakthrough therapy designation (BTD) status for use in combination with trastuzumab plus docetaxel in recurrent or metastatic breast cancer that is human epidermal growth factor receptor 2 (HER2) positive in patients not previously treated with anti-HER2 therapies. This marks another indication for the tyrosine kinase inhibitor (TKI).
Pyrotinib Profile
Pyrotinib is an in-house developed Category 1.1 EGFR/HER2 inhibitor. The drug was included on the National Reimbursement Drug List (NRDL) in 2019. It received conditional market approval in China in August 2018 and full market approval for use in HER2-positive advanced or metastatic previously treated breast cancer in combination with capecitabine in July 2020. The market filing for the drug with the said indication was accepted for review in China early last month.
Future Development
The BTD status underscores the potential of pyrotinib to address significant unmet needs in the treatment of HER2-positive breast cancer. Hengrui Medicine’s commitment to advancing innovative therapies is highlighted by the drug’s continued progress through regulatory channels, aiming to improve patient outcomes and expand treatment options in this challenging disease area.-Fineline Info & Tech
