European Commission Grants First-Ever Approval for TGCT Therapy
The European Commission has approved ROMVIMZA (vimseltinib) for the treatment of adult patients with symptomatic tenosynovial giant cell tumour (TGCT) across the European Union.
The decision represents the first marketing authorisation for a TGCT therapy in Europe, marking a milestone for patients, clinicians, and the pharmaceutical industry.
A New Option for Patients with Limited Choices
Vimseltinib is indicated for patients experiencing physical function deterioration from TGCT where surgical intervention is either not feasible or would result in unacceptable harm.
For many individuals, surgery has traditionally been the only available option, often carrying risks of recurrence or functional impairment. The arrival of a non-invasive alternative signals a significant advancement in patient care.
The approval was jointly announced by Ono Pharmaceutical and Deciphera, who co-developed the treatment. The President and CEO of Deciphera, described the decision as a significant milestone not only for the company and its partner but also for patients across the EU.
They commented that the European Commission’s approval of vimseltinib for TGCT is a significant milestone for Deciphera, ONO and TGCT patients across the European Union who are in need of a non-invasive treatment option.
Furthermore, they are excited to leverage their global commercial infrastructure to bring vimseltinib to these patients.
Addressing a Disease That Disrupts Daily Life
TGCT is a rare condition that can cause severe pain, joint stiffness, and reduced mobility, often interfering with the daily lives of patients.
A representative from the Leon Berard Center highlighted the significance of the approval, noting that vimseltinib is a differentiated therapy that has demonstrated the ability to meet previously unmet needs while maintaining a manageable safety profile.
Robust Evidence from MOTION and Early Trials
The EC’s decision is based on results from the pivotal Phase 3 MOTION study alongside supportive data from a Phase 1/2 trial. Patients treated with vimseltinib demonstrated statistically significant improvements in range of motion, physical function, and pain at week 25 compared to placebo.
Secondary endpoints also showed benefits across six measures, including tumour response, stiffness, and overall quality of life. Long-term data reinforced the therapy’s potential: by week 97, 23% of patients achieved a complete response, with a median time to response of 11.5 months.
The safety profile of vimseltinib was consistent with previous clinical data and deemed manageable, further strengthening its value as a treatment option. Full prescribing information has been made available in the Summary of Product Characteristics.
Looking Ahead
The approval of ROMVIMZA marks a new era for TGCT patients in Europe, many of whom have faced limited or invasive treatment options. With its demonstrated ability to improve physical function, reduce pain, and deliver durable tumour responses, vimseltinib provides hope for a better quality of life.
As Ono Pharmaceutical and Deciphera prepare to bring the therapy to market, the decision underscores the importance of innovative, targeted treatments in addressing rare but debilitating diseases.
For TGCT patients across the EU, this is not just an approval – it is the arrival of a long-awaited alternative.
News Credits: European Commission approves ROMVIMZA for TGCT treatment
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