Shots:
- The NMPA has approved Merck KGaA‘s Pimicotinib (PO) for the treatment of adults with symptomatic TGCT, where surgical resection can lead to functional limitation or relatively severe morbidity
- Approval 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 to pimicotinib (n=63) or PBO (n=31) for 24wks., followed by open-label Part 2 & an extension in Part 3
- Trial showed improved ORR per RECIST v1.1 (1EP; 54% vs 3.2%) at 25wks., with significant improvements in 2EPs, incl. a relative range of motion, physical function, & reduced worst stiffness & pain as presented at ASCO’25; At ESMO’25, with mFU of 14.3mos. ORR increased to 76.2%
Ref: Businesswire | Image: Merck KGaA | Press Release
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