Ono Pharmaceutical Reports the EMA’s Acceptance of MAA for Vimseltinib to Treat Tenosynovial Giant Cell Tumor (TGCT)
Shots:
- The EMA has accepted Deciphera’s (Ono’s subsidiary) MAA of vimseltinib to treat tenosynovial giant cell tumor (TGCT) for its review across the EU plus Iceland, Liechtenstein & Norway
- The MAA was supported by a P-III (MOTION) trial assessing the safety & efficacy of vimseltinib vs PBO in TGCT patients naïve to anti-CSF1/CSF1R therapy & not amenable to surgery
- At wk.25, the study depicted an ORR of 40% vs 0% in the ITT population with significant improvements in 2EPs of ORR by tumor volume score (TVS), active range of motion (ROM), physical function, stiffness, quality of life & pain; safety profile was manageable & consistent with its P-I/II trial. Results were highlighted at ASCO 2024
Ref: Ono Pharmaceutical | Image: ONO Pharmaceutical
Related News:- ONO Pharmaceutical Reports Acquisition of Deciphera Pharmaceuticals for $2.4B
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
