Deciphera Pharmaceuticals Reports the EC’s Approval of Romvimza for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)

Shots:The EC has approved Romvimza (vimseltinib) to treat symptomatic TGCT with physical function deterioration in adults for which surgery may lead to functional impairment or severe morbidityApproval was based on P-I/II trial as well as P-III (MOTION) trial, which evaluated Romvimza vs PBO in surgery-ineligible pts without prior anti-CSF1/CSF1R therapy (prior imatinib/nilotinib allowed)…

ByRidhi RastogiSeptember 18, 2025

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Deciphera Pharmaceuticals Reports the CHMP’s Positive Opinion of Romvimza for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)

Shots:The CHMP has recommended Romvimza (vimseltinib) to treat symptomatic TGCT with physical function deterioration in adults for which surgery may lead to functional impairment or severe morbidity; EC’s decision is expected in Q3'25Opinion was based on P-I/II trial as well as P-III (MOTION) trial, which evaluated Romvimza vs PBO in surgery-ineligible pts without…

ByRidhi RastogiJuly 29, 2025

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Merck KGaA to Present P-III (MANEUVER) Trial Data of Pimicotinib for Tenosynovial Giant Cell Tumor at ASCO 2025

Shots:Part 1 of P-III (MANEUVER) trial assessed pimicotinib (n=63) vs PBO (n=31) for 24wks. in 94 TGCT pts who required systemic therapy & had no prior anti-CSF-1/CSF-1R treatment; trial also incl. an open-label Part 2 (data expected in mid-2025) & an OLE phase (Part 3)Trial met its 1EP of improved ORR (54.0% vs…

ByRidhi RastogiMay 28, 2025

Deciphera Pharmaceuticals Reports the EC’s Approval of Romvimza for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)

Deciphera Pharmaceuticals Reports the CHMP’s Positive Opinion of Romvimza for Symptomatic Tenosynovial Giant Cell Tumor (TGCT)

Merck KGaA to Present P-III (MANEUVER) Trial Data of Pimicotinib for Tenosynovial Giant Cell Tumor at ASCO 2025

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