Summary

This AI-generated content is provided without warranty, with no liability accepted for reliance on it. Learn more.

• This summary is based on the review of one randomized controlled trial. ^[1]
• Romvimza (vimseltinib) is indicated for treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
• This summary is based on the review of a randomized controlled trial.
• Among adults with tenosynovial giant cell tumor (TGCT) not amenable to surgery, the objective response rate (ORR) at week 25 was 40% (33/83 patients) in the vimseltinib group compared to 0% (0/40 patients) in the placebo group.
• The difference in ORR between vimseltinib and placebo was 40% (95% CI 29–51; p<0.0001), demonstrating statistical significance.
• In patients with symptomatic tenosynovial giant cell tumor (TGCT) not amenable to surgery, 10% (8 of 83) of those receiving vimseltinib experienced grade 3 or 4 increased blood creatine phosphokinase; one patient had a treatment-related serious adverse event of subcutaneous abscess.
• No evidence of cholestatic hepatotoxicity or drug-induced liver injury was observed.
• There is no population types or subgroups information available in the reviewed studies.