Nirogacestat

Nirogacestat (Ogsiveo, Merck Europe B.V.) has 1 EU-approved indication in 1 tumour type.
Approved indications of Nirogacestat
Biomarker requirementRegimenSettingConditions
Desmoid tumour1
None
Monotherapy
Any line
Progressing; requiring systemic treatment
Full text of section 4.1 (therapeutic indications)

Ogsiveo as monotherapy is indicated for the treatment of adult patients with progressing desmoid tumours who require systemic treatment.

Label history

5 changes to the Ogsiveo label since 2026, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes