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news.The US Food and Drug Administration (FDA) has granted approval for Deciphera Pharmaceuticals’ Romvimza (vimseltinib) to treat adults with symptomatic tenosynovial giant cell tumour (TGCT).
With the approval, the company plans to make the therapy commercially available in the US next week. Credit: National Cancer Institute on Unsplash.
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Romvimza is indicated for use in TGCT patients for whom surgery could worsen functional limitations or cause severe morbidity.
The approval is based on the results from the randomised, double-blind, placebo-controlled Phase III MOTION study of Romvimza in patients with inoperable TGCT who had not received prior anti-CSF1/CSF1R therapy, and data from the Phase I/II study.
The MOTION trial assessed the efficacy and safety of vimseltinib versus placebo.
Its primary endpoint was to measure the objective response rate (ORR) at week 25 in the intent-to-treat (ITT) population in comparison to a placebo.
Secondary endpoints included ORR per tumour volume score, physical function, active range of motion, stiffness, quality of life, and pain, all evaluated at week 25.
In the MOTION study, Romvimza demonstrated a statistically significant and clinically meaningful ORR at week 25 in the ITT population compared to the placebo group.
These results were further supported by improvements in active range of motion, patient-reported physical functioning, and pain in the vimseltinib arm versus the placebo arm at week 25.
Romvimza’s safety profile was found to be manageable and in line with the Phase I/II clinical trial findings.
With the approval, Deciphera plans to make the therapy commercially available in the US next week.
Deciphera Pharmaceuticals president and CEO Ryota Udagawa said: “The FDA approval of Romvimza for TGCT is a crucial advancement for the TGCT community and we believe Romvimza has the potential to become the new standard of care for people with TGCT for which surgical resection will potentially cause worsening functional limitation or severe morbidity.
“This is also an important milestone for our organisation, as it is the second approved therapy discovered using Deciphera’s proprietary switch-control kinase inhibitor platform.”
In July 2024, the European Medicines Agency accepted to review the company’s marketing authorisation application for Romvimza for TGCT treatment.
