Shots:
- The NMPA has accepted the MAA of Pimicotinib (QD) for adults with TGCT needing systemic therapy
- The 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 incl. an open-label Part 2 for up to 24 wks. (data expected in mid-2025); those completing Part 2 may continue to Part 3 for extended treatment and safety follow-up
- The trial met its 1EP of improved ORR (54% vs 3.2%) at 25wks., it showed significant improvements in 2EPs, including a range of motion, physical function, stiffness, and pain;data waspresented at the ASCO 2025
Ref: Businesswire | Image: Merck KGa | Press Release
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