Lisocabtagene Maraleucel
Antineoplastic Cell and Gene Therapy
Sold as Breyanzi
- Drug class
- Antineoplastic Cell and Gene Therapy
- Availability
- See label
- Routes
- Intravenous
- Markets covered
- 3
- Products on record
- 3
Overview
Lisocabtagene Maraleucel is an active pharmaceutical ingredient in the Antineoplastic Cell and Gene Therapy group (L01XL). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.
Regulatory status by market
| Market | Regulator | Products | Last revision |
|---|---|---|---|
| EU European Union | EMA | 1 | December 18, 2025 |
| CA Canada | Health Canada | 1 | October 30, 2025 |
| GB United Kingdom | MHRA | 1 | May 15, 2026 |
EUEuropean Union· EMA
1 product
Uses
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.
CACanada· Health Canada
1 product
Uses
1. of the PM Guidance) or subsections that are not applicable at the time of the preparation of the most recent authorized product monograph are not listed. Recent Major Label Changes .................................................................................................
2 Table of Contents ................................................................................................................. 2 Part 1: Healthcare Professional Information..........................................................................
5 1. Indications..................................................................................................................... 1. Pediatrics....................................................................................................................
2. Geriatrics .................................................................................................................... 5 2. Contraindications ..........................................................................................................
GBUnited Kingdom· MHRA
1 product
1 product on record with this regulator. Detailed label text (uses, dosage, side effects) is being ingested — the original document is linked under Sources [3].
Drug interactions
Known interactions involving Lisocabtagene Maraleucel. Select one for details. This list is informational and not a complete interaction checker.
Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.
Sources & citations
- [1]European Medicines Agency · EMEA/H/C/004731 · revised December 18, 2025
- [2]Health Canada (DPD) · 02527138 · revised October 30, 2025
- [3]MHRA (UK) · PLGB151050152 · revised May 15, 2026
Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.