Cstone pharmaceuticals received approval in China for a new indication for Pugehua

2022-05-03 0 By

Cstone Pharmaceuticals announced that the Extended indication application for the selective RET inhibitor Pujihua ® (Pratinib capsule) has been approved by the National Medical Products Administration of China (NMPA).This expanded indication includes the treatment of adults and children 12 years and older with advanced or metastatic transfection rearrangement (RET) mutant medullary thyroid carcinoma (MTC) requiring systemic treatment,And the treatment of adults and children 12 years and older with advanced or metastatic RET fusion positive thyroid cancer (TC) requiring systemic therapy and refractory to radioactive iodine if appropriate.This is a successful extension of the indication for Pujciva ® following NMPA approval in March 2021 for locally advanced or metastatic non-small cell lung cancer (NSCLC) in which RET fusion is positive after prior platinum-containing chemotherapy.Pudgva is also the first and only approved selective RET inhibitor for RET mutated MTC and RET fusion positive TC in China.