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BioWorld - Thursday, March 26, 2026
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Home » Deciphera’s Romvimza wins FDA nod for tenosynovial giant cell tumors
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Deciphera’s Romvimza wins FDA nod for tenosynovial giant cell tumors

Feb. 18, 2025
By Karen Carey
Becoming the second drug approved by the U.S. FDA for tenosynovial giant cell tumors, Deciphera Pharmaceuticals Inc.’s oral CSF1R inhibitor vimseltinib, newly branded Romvimza, could take significant market share from a competitor in the same class. A phase III trial showed a higher objective response rate with Romvimza than a separate phase III trial showed with Daiichi Sankyo Co. Ltd.’s Turalio (pexidartinib), and the latter’s label contains a boxed warning on rare but serious and sometimes life-threatening liver side effects.
BioWorld Regulatory Immune Small molecule U.S. FDA

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