Treats symptomatic tenosynovial giant cell tumor (TGCT). NDA 219304, held by Deciphera Pharms. Vimseltinib.
As of Nov 13, 2026, NDA 219304 (Romvimza), held by Deciphera Pharms, was first approved by FDA on Feb 14, 2025, with 2 approved supplements and 0 published complete response letters.
ROMVIMZA 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.
| Jun 26, 2026 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Feb 14, 2025 | Original applicationNew molecular entity · Priority review | Approved |
| Romvimza14MG · capsule;oral | Vimseltinib | RxReference drug |
| Romvimza20MG · capsule;oral | Vimseltinib | RxReference drug |
| Romvimza30MG · capsule;oral | Vimseltinib | RxReference drug |
| Jun 26, 2026 | Supplement 2Efficacy (new indication or use) · Standard review | Approved | |
| Dec 12, 2025 | Supplement 1Labeling · Standard review | Approved | |
| Feb 14, 2025 | Original applicationNew molecular entity · Priority review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
