Vimseltinib FDA Approval Status
Last updated by Judith Stewart, BPharm on Aug 19, 2024.
FDA Approved: No
Generic name: vimseltinib
Company: Deciphera Pharmaceuticals, Inc.
Treatment for: Tenosynovial Giant Cell Tumor
Vimseltinib is a switch-control kinase inhibitor of colony stimulating factor 1 receptor (CSF1R) in development for the treatment of patients with tenosynovial giant cell tumor.
- Tenosynovial giant cell tumor (TGCT) is a rare, non-malignant tumor that develops inside or near the joints. It is caused by a dysregulation in the colony-stimulating factor 1 (CSF1) gene resulting in overexpression of CSF1 and recruitment of CSF1R-positive inflammatory cells into the lesion. Although benign, the tumors can grow and cause damage to surrounding tissues and structures inducing pain, swelling, and limitation of movement of the joint.
- Vimseltinib works in the treatment of TGCT by selectively and potently inhibiting CSF1R.
- The New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) was supported by data from the pivotal Phase 3 MOTION study, where vimseltinib demonstrated a statistically significant and clinically meaningful objective response rate compared to placebo.
- The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 17, 2025.
Development timeline for vimseltinib
Further information
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