Every dated change on the records linked to Tenosynovial giant cell tumour (TGCT), newest first: approvals and regulatory steps on its medicines, trials that reported, guideline versions, milestones, and when this page itself was checked. Dates come from the records; none is inferred. Orientation, not medical advice.
Symptomatic TGCT where surgery has been exhausted or would cause unacceptable morbidity; 17 Sep 2025
Symptomatic tenosynovial giant cell tumour where surgery would worsen function or cause severe morbidity
FDA approval 14 February 2025 for symptomatic TGCT where surgery would worsen function.
Symptomatic tenosynovial giant cell tumour not amenable to surgery
Week 25 RECIST response 39% vs 0% (placebo); FDA approval 2019 with a liver-toxicity REMS.
First systemic therapy approved for TGCT (August 2019), with a boxed hepatotoxicity warning.