TOC
【FDA Approval Alert】Deciphera’s vimseltinib (Romvimza) Approved for TGCT (February 14, 2025)
On February 14, 2025, the U.S. FDA approved vimseltinib (Romvimza) for adult patients with symptomatic tenosynovial giant cell tumor (TGCT) where surgical resection would likely cause worsening functional limitation or severe morbidity. Approval was based on the MOTION trial (NCT05059262).
Disease Overview: Tenosynovial Giant Cell Tumor (TGCT)
TGCT is a rare benign tumor of synovial tissues around joints, leading to swelling, pain, and reduced mobility. For inoperable cases, targeted therapies offer a non-surgical option.
Treatment Summary
- Drug Name: vimseltinib (Romvimza)
- Company: Deciphera Pharmaceuticals, LLC
- Approval Date: February 14, 2025
- Indication: Symptomatic TGCT where surgery would cause functional impairment
- Mechanism of Action: CSF1 receptor (CSF1R) inhibitor
- Pivotal Trial: MOTION (NCT05059262)
- Key Efficacy:
- ORR: 40% vs 0% (p<0.0001)
- Median DOR: Not reached; 85% DOR ≥6 months, 58% DOR ≥9 months
Patient-Friendly Summary
Romvimza inhibits tumor cell growth in TGCT, providing a new oral treatment for patients who are not candidates for surgery.
M&A Information
- Subsidiary: Not applicable (Deciphera in-house development)
- Acquisition Date: Not applicable
- Development Stage at Acquisition: Not applicable
- Investor Information: Public Investors (NASDAQ: DCPH)
Source
This approval information is based on data from Drugs@FDA (U.S. FDA) and AACR releases.
