FDA Approves Pimjetmi for Tenosynovial Giant Cell Tumor

The U.S. FDA has approved Merck KGaA's Pimjetmi (pimicotinib), an oral CSF-1R inhibitor, for symptomatic tenosynovial giant cell tumor (TGCT) in adults where surgery could worsen functional limitations or cause severe morbidity. This approval offers a third treatment option for the rare, non-cancerous tumor that causes joint inflammation and destruction. The Phase 3 MANEUVER trial supported the approval, showing a 56% objective response rate for Pimjetmi versus 3% for placebo.