Jiangsu Hengrui Pharmaceuticals (SHA: 600276), a leading China-based pharmaceutical company, has announced receiving another indication approval from the National Medical Products Administration (NMPA) for its small-molecule HER2 inhibitor, pyrotinib. The drug is now approved for use in combination with Herceptin (trastuzumab) plus chemotherapy to treat 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’s Inclusion and Previous Approvals
Pyrotinib, an in-house developed innovative EGFR/HER2 inhibitor, was included on the National Reimbursement Drug List (NRDL) in 2019. Its first market approval in China in August 2018 was for use in HER2-positive advanced or metastatic breast cancer that had been previously treated, in combination with capecitabine.
Phase III Study Results and New Indication Approval
The latest indication approval for pyrotinib is based on the results of the randomized, double-blind, parallel-controlled, multi-center Phase III HR-BLTN-III-MBC-C study. This study successfully reached its primary endpoint of improved progression-free survival (PFS), demonstrating the efficacy of pyrotinib in combination with Herceptin and chemotherapy for the treatment of HER2-positive breast cancer in patients who have not been previously treated with anti-HER2 therapies.-Fineline Info & Tech
