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NMPA Conditionally Approves the Marketing of Pralsetinib Capsule

2021-03-24 5329

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).

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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.