NMPA (China) approval of Gavreto for the treatment of advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion-positive thyroid cancer.- CStone Pharma.
CStone Pharmaceuticals announced that the National Medical Products Administration (NMPA) of China has approved the supplemental new drug application (sNDA) of selective RET inhibitor Gavreto (pralsetinib) for the treatment of RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancer (TC).
The approval expanded the labeled indications of Gavreto in China to include adult and pediatric patients 12 years of age and older with advanced or metastatic RET-mutant MTC who requires systemic therapy, and adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive TC who requires systemic therapy and radioactive iodine-refractory (if radioactive iodine treatment is appropriate).
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