PIMJETMI® (Pimicotinib) Developed by Abbisko Therapeutics and Licensed by Merck KGaA, Darmstadt, Germany Receive U.S. FDA Approval for TGCT
The oral CSF-1R inhibitor showed a 54% response rate at week 25 in the MANEUVER trial, far above placebo, the FDA said.
- On Tuesday, the U.S. Food and Drug Administration approved PIMJETMI as a systemic treatment for adults with symptomatic tenosynovial giant cell tumor where surgical resection poses risks of functional limitation or severe morbidity.
- TGCT is a rare, locally aggressive condition affecting joints and tendon sheaths that causes pain, stiffness, and mobility limitations, often requiring treatments beyond primary surgical resection.
- Data from the Phase III MANEUVER study showed a 54% objective response rate versus 3% for placebo, with 77% of patients maintaining clinical benefit after 12 months of follow-up, demonstrating durable tumor response.
- Following authorizations in China, Canada, and Switzerland, this marks the fourth marketing approval as Abbisko Therapeutics Co., Ltd. accelerates global commercialization with partner Merck KGaA, Darmstadt, Germany.
- Yao-Chang Xu, PhD, Founder and Chief Executive Officer of Abbisko Therapeutics, called the approval "a significant milestone," while Danny Bar-Zohar, CEO Healthcare and Member of the Executive Board of Merck KGaA, Darmstadt, Germany, emphasized delivering "meaningful benefit" to patients.
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PIMJETMI® (pimicotinib) Developed by Abbisko Therapeutics and Licensed by Merck KGaA, Darmstadt, Germany Receive U.S. FDA Approval for TGCT
PIMJETMI® (pimicotinib) is a new systemic treatment option for certain U.S. adult patients with symptomatic tenosynovial giant cell tumor (TGCT), demonstrating durable* tumor response with clinically meaningful improvements in certain clinical outcome assessments, including physical function and painAbbisko to receive…
Another Option for Rare Benign Soft-Tissue Tumor Wins FDA Approval
(MedPage Today) -- The FDA approved the small-molecule inhibitor pimicotinib (Pimjetmi) for selected patients with symptomatic tenosynovial giant cell tumor (TGCT) and high surgical risk. An oral selective inhibitor of colony stimulating factor...
FDA Approves PIMJETMI® (pimicotinib) for Patients with Tenosynovial Giant Cell Tumor
BOSTON--(BUSINESS WIRE)--EMD Serono, the Healthcare business of Merck KGaA, Darmstadt, Germany, in the US and Canada, announced today that the U.S. Food and Drug Administration (FDA) has approved PIMJETMI® (pimicotinib), a once-daily oral colony stimulating factor-1 receptor (CSF-1R) inhibitor, as a systemic treatment for adults with symptomatic tenosynovial giant cell tumor (TGCT) for which surgical more...
FDA Approves PIMJETMI® (pimicotinib) for Patients with Tenosynovial Giant Cell Tumor – Novumpr
PIMJETMI is a new once-daily oral systemic treatment option for certain U.S. patients with symptomatic tenosynovial giant cell tumor (TGCT) In the Phase 3 MANEUVER trial, PIMJETMI demonstrated early1 and durable2 tumor response with clinically meaningful improvements in all clinical outcome assessments, including physical function and pain PIMJETMI has shown high objective response rate (ORR) […]
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