The Center for Drug Evaluation (CDE) website has announced that China-based Hengrui Pharmaceuticals’ (SHA: 600276) pyrotinib has been granted priority review status. The drug is being evaluated for use in combination with trastuzumab and docetaxel for the treatment of recurrent or metastatic breast cancer that is human epidermal growth factor receptor 2 (HER2) positive, specifically in patients who have not previously received anti-HER2 therapies. This indication recently earned pyrotinib a breakthrough therapy designation (BTD) earlier this month.
Pyrotinib Background
Pyrotinib is an in-house developed Category 1.1 EGFR/HER2 inhibitor. The drug was included on China’s 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 breast cancer previously treated with other therapies in combination with capecitabine in July 2020. The market filing for this new indication was accepted for review in China early last month.-Fineline Info & Tech
