Merck KGaA's Pimjetmi Gets US FDA Nod for Rare Joint Tumor

11:23 PM EST, 11/10/2026 (MT Newswires) -- Merck KGaA (MRK.F) received US Food and Drug Administration approval for Pimjetmi to treat adults with symptomatic tenosynovial giant cell tumor. The German science and technology company said Tuesday the oral drug, also known as pimicotinib, is indicated as a once-daily treatment for US patients with the rare, locally aggressive tumor occurring in or around the joints, where surgery could cause worsening functional limitations or severe complications. The decision was based on positive results from the ongoing phase 3 Maneuver trial, in which Pimjetmi showed "early and durable" tumor response. The company previously received approval for Pimjetmi in China, Canada, and Switzerland.