Lisocabtagene maraleucel

Lisocabtagene maraleucel (Breyanzi, Bristol-Myers Squibb Pharma EEIG) has 5 EU-approved indications in 3 tumour types.
Approved indications of Lisocabtagene maraleucel
Biomarker requirementRegimenSettingConditions
Large B-cell lymphoma2
None
Monotherapy
2L
DLBCL, HGBL or PMBCL only; Relapsed within 12 months from completion of, or refractory to, first-line chemoimmunotherapy
None
Monotherapy
3L+
DLBCL or PMBCL only; After two or more lines of systemic therapy
Follicular lymphoma2
None
Monotherapy
2L
Grade 3B only; Relapsed within 12 months from completion of, or refractory to, first-line chemoimmunotherapy
None
Monotherapy
3L+
After two or more lines of systemic therapy
Mantle cell lymphoma1
None
Monotherapy
3L+
After at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor
Full text of section 4.1 (therapeutic indications)

Breyanzi is indicated for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. Breyanzi is indicated for the treatment of adult patients with relapsed or refractory DLBCL, PMBCL and FL3B, after two or more lines of systemic therapy. Breyanzi is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Breyanzi is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.

Label history

11 changes to the Breyanzi label since 2023, 3 of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes