Loncastuximab tesirine

Loncastuximab tesirine (Zynlonta, Swedish Orphan Biovitrum AB) has 1 EU-approved indication in 1 tumour type.
Approved indications of Loncastuximab tesirine
Biomarker requirementRegimenSettingConditions
Large B-cell lymphoma1
None
Monotherapy
3L+
DLBCL or HGBL only; After two or more lines of systemic therapy; Relapsed or refractory
Full text of section 4.1 (therapeutic indications)

Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.

Label history

10 changes to the Zynlonta label since 2023, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes