U.S. Food and Drug Administration Accepts for Priority Review Deciphera’s New Drug Application for Vimseltinib for the Treatment of Patients with Tenosynovial Giant Cell Tumor (TGCT)
The FDA accepted a priority review for Deciphera's vimseltinib NDA for treating TGCT, with a PDUFA goal date of Feb 17, 2025. Vimseltinib, a CSF1R inhibitor, showed significant efficacy in the Phase 3 MOTION study, presenting an ORR of 40% vs 0% with placebo. The EMA also started its review process for vimseltinib in mid-July.
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The FDA granted priority review to vimseltinib, an oral tyrosine kinase inhibitor for tenosynovial giant cell tumors (TGCTs), with a goal date of February 17, 2025. The phase 3 MOTION trial showed vimseltinib significantly improved objective response rate (ORR) vs placebo, with no cholestatic hepatotoxicity. Common AEs included periorbital edema, fatigue, and facial edema. Vimseltinib could shift TGCT treatment, emphasizing patient quality of life and potentially reducing surgical intervention.
Vimseltinib showed promising efficacy and safety in treating tenosynovial giant cell tumor (TGCT), with a 40% objective response rate (ORR) vs. 0% for placebo in the MOTION trial. Improvements in quality of life (QOL) were also noted, with a benign adverse event profile. The FDA granted priority review for vimseltinib in August 2024, with a decision target date of February 17, 2025.
The FDA accepted a priority review for Deciphera's vimseltinib NDA for treating TGCT, with a PDUFA goal date of Feb 17, 2025. Vimseltinib, a CSF1R inhibitor, showed significant efficacy in the Phase 3 MOTION study, presenting an ORR of 40% vs 0% with placebo. The EMA also started its review process for vimseltinib in mid-July.