Is Lisocabtagene maraleucel authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Lisocabtagene maraleucel: Breyanzi.

Are there safety signals or safety updates for Lisocabtagene maraleucel?

EMA PRAC: 6 entries (latest 2025-06-05).

Active substance

Lisocabtagene maraleucel

EMA 1
Health Canada 1
Safety 6

Open in the medicines table

EMA European Union — centrally authorised medicines

Breyanzi Bristol-Myers Squibb Pharma EEIG · Authorised · authorised 4 Apr 2022 · ATC L01XL08

Therapeutic indication (EMA)

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.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
BREYANZI	02527138	120000000 CELLS	SUSPENSION · INTRAVENOUS	BRISTOL-MYERS SQUIBB CANADA

Safety signals and safety-related labeling changes

EMA PRAC 5 Jun 2025 PRAC signal: Immune-mediated enterocolitis / immune effector cell-associated enteritis with CAR T-cell products
Action for MAH: update of the product information: Yes
EMA PRAC 16 Jan 2025 PRAC signal: Immune-mediated enterocolitis
Action for MAH: update of the product information: No
EMA PRAC 5 Sep 2024 PRAC signal: Progressive multifocal leukoencephalopathy
Action for MAH: update of the product information: No
EMA PRAC 13 Jun 2024 PRAC signal: Secondary malignancy of T-cell origin
Action for MAH: update of the product information: Yes
EMA PRAC 11 Apr 2024 PRAC signal: Secondary malignancy of T-cell origin
Action for MAH: update of the product information: No
EMA PRAC 11 Jan 2024 PRAC signal: Secondary malignancy of T-cell origin
Action for MAH: update of the product information: No

All safety entries for lisocabtagene maraleucel →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.