FDA approves vimseltinib for tenosynovial giant cell tumor

Vimseltinib Benefits More Than Two-Thirds of Patients

Dr. Tap previously presented findings from the MOTION trial in June 2024 at the annual meeting of the American Society of Clinical Oncology. The research was also published in The Lancet at the time of his presentation, and he was co-corresponding author of the paper.

That study included 123 patients, 83 of whom got vimseltinib and 40 of whom got a placebo. The investigators reported that 67% of patients receiving vimseltinib had measurably reduced tumor volume, compared with none in the placebo group.

Additionally, patients in the trial who received vimseltinib reported improvement in several important measures, including:

• Range of motion
• Physical function
• Joint stiffness
• Pain
• Overall health

Vimseltinib Has Fewer Side Effects than Pexidartinib

Dr. Tap previously led clinical trials for another drug for TGCT, called pexidartinib (Turalio®). That drug received approval from the FDA in 2019. But because it can cause liver damage in some patients, investigators sought additional options.

This trial found that vimseltinib had far fewer side effects than pexidartinib. The most common ones were swelling, rash, headaches, and feeling tired, but none were severe.

Importantly, the drug did not appear to cause liver injury in any patients who received it. This is significant because patients need to stay on these medicines long-term to keep their tumors under control.

“We believe that vimseltinib is another wonderful option to consider in treating people with TGCT,” Dr. Tap says.