Odronextamab

Odronextamab (Ordspono, Regeneron Ireland Designated Activity Company (DAC)) has 2 EU-approved indications in 2 tumour types.
Approved indications of Odronextamab
Biomarker requirementRegimenSettingConditions
Large B-cell lymphoma1
None
Monotherapy
3L+
DLBCL only; After two or more lines of systemic therapy
Follicular lymphoma1
None
Monotherapy
3L+
After two or more lines of systemic therapy
Full text of section 4.1 (therapeutic indications)

Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after two or more lines of systemic therapy. Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) after two or more lines of systemic therapy.

Label history

2 changes to the Ordspono label since 2025, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes