FDA Grants Approval for Pimicotinib to Treat Rare Tumor

The U.S. FDA has approved pimicotinib (Pimjetmi), an oral kinase inhibitor, for adults with symptomatic tenosynovial giant cell tumor (TGCT) where surgery is not ideal due to potential functional limitations or severe morbidity. This approval, based on the Phase 3 MANEUVER trial, offers a new once-daily oral treatment option for this rare and locally aggressive tumor. It represents a significant development for patients previously facing limited therapeutic choices.