The U.S. Food and Drug Administration approved pimicotinib (Pimjetmi) for adults with symptomatic tenosynovial giant cell tumors (TGCT) when surgery would cause worsening functional limitations or severe morbidity. The kinase inhibitor approval was based on results from the phase 3 MANEUVER trial. In MANEUVER, pimicotinib delivered an objective response rate of 54% at week 25 versus 3% with placebo, per RECIST v1.1 criteria, with the FDA describing a manageable tolerability profile. The product carries warnings including hepatotoxicity, embryo-fetal toxicity, and increased serum creatinine. The approval reinforces a continued shift toward non-surgical options in TGCT, where symptom burden can be persistent and functional outcomes are central to treatment decisions. Clinicians will now be able to incorporate pimicotinib for patients meeting the approval’s risk-of-surgery criteria.