Shots:The NMPA has accepted the MAA of Pimicotinib (QD) for adults with TGCT needing systemic therapyThe application was based on Part 1 of the P-III (MANEUVER) global study, trial assessed pimicotinib (n=63) vs PBO (n=31) for 24wks. in 94 TGCT pts who required systemic therapy & had no prior anti-CSF-1/CSF-1R treatment, the trial also…
Shots:The US FDA has approved Romvimza to treat symptomatic TGCT in adults for which surgery may lead to functional impairment or severe morbidity. Commercially available in the US by Feb 2025, whereas MAA is under EMA review
Approval was based on P-I/II trial as well as P-III (MOTION) trial, which evaluated Romvimza vs…

