Shots:
The US FDA has accepted the NDA of Merck KGaA's Pimicotinib (PO) for the systemic treatment of adults with TGCT following NMPA approval
NDA was based on the global 3-part P-III (MANEUVER) trial in TGCT pts who require systemic therapy & have not received prior anti-CSF-1/CSF-1R therapy, in which Part 1 randomized 94 pts…
Shots:
Part 1 of P-III (MANEUVER) 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; trial also incl. an open-label Part 2 (data expected in mid-2025) & an OLE phase (Part 3)
Trial met its 1EP of improved ORR (54.0% vs…

