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Merck receives EU approval for first drug against desmoid tumours

Merck has received approval for Ogsiveo from the European Commission, marking a breakthrough in the treatment of rare tumours. The drug with the active ingredient nirogacestat is the first approved therapy for patients with desmoid tumours in the European Union. The EU decision is based on the results of the international phase III DeFi study, which impressively showed that Ogsiveo was able to reduce the progression of the disease by more than seventy per cent and achieved significantly better response rates than placebo.

18/08/2025

Patients also reported noticeable pain relief and an improvement in their quality of life. Desmoid tumours are considered to be particularly burdensome as they grow locally aggressively, are difficult to treat and are associated with high recurrence rates. Around two thousand people are diagnosed with desmoid tumours in Europe every year. Until now, no authorised medication has been available for these patients. The decision from Brussels opens up new perspectives for sufferers, their families and treating physicians for the first time. For Merck, the approval means further strengthening in the field of rare tumour diseases. Following the recent approval of a further therapy for neurofibromatosis-related tumours, the company is consistently expanding its position as one of the central providers of innovative treatments for rare diseases in Europe.

News of "Merck KGaA" from 18 August 2025

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