Ono Pharmaceutical Reports the US FDA Approval of Romvimza to Treat Symptomatic Tenosynovial Giant Cell Tumor (TGCT) in Adults

Shots:

• The US FDA has approved Romvimza to treat symptomatic TGCT in adults for which surgery may lead to functional impairment or severe morbidity. Commercially available in the US by Feb 2025, whereas MAA is under EMA review
• Approval 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 in 2 parts, where PBO pts could switch to Romvimza in part 2 after 24wks.
• The P-III trial met its 1EP of improved ORR (40% vs 0%) in ITT pts, plus its 2EPs of ORR per TVS, improved active range of motion, patient-reported physical functioning, & pain observed at 25wks., with favorable safety as depicted by P-I/II data

Ref: Businesswire | Image: Ono Pharmaceutical

Related News:- Ono Pharmaceutical Reports the EMA’s Acceptance of MAA for Vimseltinib to Treat Tenosynovial Giant Cell Tumor (TGCT)

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