Breyanzi - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation

lisocabtagene maraleucel

Opinion

On 16 October 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending a change to the terms of the marketing authorisation for the medicinal product Breyanzi. The marketing authorisation holder for this medicinal product is Bristol-Myers Squibb Pharma EEIG.

The CHMP adopted a new indication:

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.

For information, the full indications for Breyanzi will now be:

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.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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Note: New text in bold.

CHMP post-authorisation summary of positive opinion for Breyanzi (II-EMAVR0000265024)

Adopted

Key facts

• Name of medicine:
  Breyanzi
• EMA product number:
  EMEA/H/C/004731
• Active substance:
  • CD19-directed genetically modified autologous cell-based product consisting of purified CD8+ T-cells (CD8+ cells)
  • CD19-directed genetically modified autologous cell-based product consisting of purified CD4+ T cells (CD4+ cells)
• International non-proprietary name (INN) or common name:
  lisocabtagene maraleucel
• Therapeutic area (MeSH):
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Follicular
  • Mediastinal Neoplasms
• Anatomical therapeutical chemical (ATC) code:
  L01XL08
• Additional monitoring:

  This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

• Advanced therapy:

  This medicine is classified as an advanced therapy medicinal product (ATMP): a medicine for human use that is based on genes, tissues or cells. It offers groundbreaking new opportunities for the treatment of disease and injury. For more information, see Advanced therapy medicinal products: Overview.

• PRIME: priority medicine:

  This medicine was granted entry to the EMA Priority Medicines (PRIME) scheme during its development. PRIME is a scheme launched by EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. For more information, see PRIME: priority medicines.

• Marketing authorisation holder:
  Bristol-Myers Squibb Pharma EEIG
• Date of opinion:
  16/10/2025
• Status:
  Positive