The Babak Lab/LinkedIn
Feb 26, 2025, 11:56
The FDA has approved vimseltinib by Deciphera Pharmaceuticals for TGCT – The Babak Lab
The Babak Lab shared a post on LinkedIn:
“Clinical Mondays Great News in Oncology!
The FDA has approved vimseltinib (Romvimza) by Deciphera Pharmaceuticals for adults with symptomatic tenosynovial giant cell tumor (TGCT) where surgery could cause severe functional limitations. This is a game-changer for patients with this rare condition!
Key Highlights:
- 40% overall response rate (ORR) with vimseltinib vs. 0% with placebo (p-value <0.0001).
- 85% of responders saw benefits lasting ≥6 months, and 58% had ≥9 months of response.
- Significant improvements in pain relief, physical function, and range of motion.
- Recommended dose: 30 mg orally twice weekly, with 72 hours between doses.
This approval highlights the power of innovation in addressing unmet medical needs. Huge congrats to Deciphera Pharmaceuticals and everyone involved!”
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