The official website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration (NMPA) has indicated that Daiichi Sankyo (TYO: 4568)’s pexidartinib (PLX3397) is on track to receive priority review status for the treatment of symptomatic giant cell tumor of the tendon sheath (TGCT) in adult patients with severe lesions or functional limitations that cannot be improved through surgery.
Pexidartinib, an oral colony stimulating factor 1 receptor (CSF1R) inhibitor, has previously been granted breakthrough therapy designation, orphan drug designation, and priority review status in the U.S. It was approved for the treatment of adult patients with symptomatic TGCT in August 2019. This approval was supported by the results of the global, multi-center Phase III ENLIVEN study, which demonstrated that 39% of patients treated with pexidartinib achieved remission after 25 weeks of treatment. The study also showed partial remission and complete remission rates of 23% and 15%, respectively.- Flcube.com
