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 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) 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 continued to increase over time in pimicotinib-treated pts
Ref: Merck KGaA | Image: Merck KGaA | Press Release
Related News: The NMPA Approves Merck KGaA’s Pimicotinib for Tenosynovial Giant Cell Tumor (TGCT)
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