U.S. FDA Approves PIMJETMI (pimicotinib) for Symptomatic Tenosynovial Giant Cell Tumor

The U.S. Food and Drug Administration (FDA) has granted marketing approval for PIMJETMI (pimicotinib), a once-daily oral treatment for adults with symptomatic tenosynovial giant cell tumor (TGCT) where surgical resection could worsen functional limitation or cause severe morbidity. This approval is based on positive results from the Phase 3 MANEUVER study, showing significant improvement in objective response rate and clinically meaningful improvements in physical function and pain.