The US FDA has approved vimseltinib for the treatment of adult patients with symptomatic tenosynovial giant cell tumor, where surgical resection could lead to worsening functional limitation or severe morbidity. Clinical evidence In clinical trials, vimseltinib achieved a 40% overall response rate (ORR) compared to 0% for placebo at week 25, with 85% of responders maintaining a response for over six months and 58% for over nine months. It also significantly improved the range of motion, physical function, and pain.
Dosage and administration Available as capsules 30 mg orally twice weekly, with a minimum of 72 hours between doses Contraindications None Warnings and precautions Hepatotoxicity Embryo-fetal toxicity Allergic reactions to FD&C Yellow No. 5 (tartrazine) and No. 6 (Sunset Yellow FCF) Increased serum creatinine without affecting renal function Adverse reactions Increased AST,…
