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NMPA Conditionally Approves the Marketing of Pralsetinib Capsule

2021-03-24 1061

Recently, through the prioritized review and approval procedure, the NMPA conditionally approved the marketing of Pralsetinib capsule, a Class 1 innovative drug declared by Blueprint Medicines Corporation. Pralsetinib is a Rearranged during Transfection (RET)inhibitor of the receptor’s tyrosine kinase, which can inhibit the activity of RET and have a dose-dependent inhibition on RET and the phosphorylation of its downstream molecules and effectively inhibit the multiplication of cells expressing RET (wild type and multiple mutant types).

The product is used in the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) positive for RET gene fusion, who have ever received platinum-containing chemotherapy. The marketing of the product has provided a new treatment option for adult patients with locally advanced or NSCLC.