FDA Approves Pimicotinib for Specific Tenosynovial Giant Cell Tumor Cases

The U.S. FDA has approved pimicotinib (Pimjetmi), a kinase inhibitor, for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) where surgery is not feasible or would worsen functional limitation. This approval is based on the phase 3 MANEUVER study, which showed a 54% objective response rate compared to 3% with placebo. The drug carries warnings for hepatotoxicity and embryo-fetal toxicity.