EMA Recommends Granting a Marketing Authorisation for Lisocabtagene Maraleucel

On 27 January 2022, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product lisocabtagene maraleucel (Breyanzi), intended for the treatment of adults with relapsed or refractory diffuse large B cell lymphoma (DLBCL), primary mediastinal large B cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), after at least two previous lines of treatments.

As Breyanzi is an advanced therapy medicinal product, the CHMP positive opinion is based on an assessment by the EMA’s Committee for Advanced Therapies.

The applicant for this medicinal product is Bristol-Myers Squibb Pharma EEIG.

Breyanzi will be available as 1.1-70 × 106 cells/mL (CD4+ cells) / 1.1-70 × 106 cells/mL (CD8+ cells) dispersion for infusion.

Breyanzi contains the following two active substances, which are covered by the single INN lisocabtagene maraleucel:

  • 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).

Breyanzi is a CD19-directed genetically modified autologous cellular immunotherapy, where the chimeric antigen receptor (CAR) binds to CD19 expressed on the cell surface of tumour and normal B cells. This induces activation and proliferation of CAR T cells, release of pro-inflammatory cytokines, and cytotoxic killing of target cells.

The benefits of Breyanzi are its ability to provide high and durable responses in patients with relapsed or refractory DLBCL, PMBCL and FL3B.

The most common side effects are neutropenia, anaemia, cytokine release syndrome, fatigue, and thrombocytopenia.

The full indication is:

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 should be prescribed by physicians experienced in the treatment of haematological malignancies and trained for administration and management of patients treated with Breyanzi.

Detailed recommendations for the use of this product will be described in the summary of product characteristics, which will be published in the European public assessment report and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Summaries of positive opinion are published without prejudice to the Commission decision, which will normally be issued 67 days from adoption of the opinion.

This product was designated as an orphan medicine during its development. EMA will now review the information available to date to determine if the orphan designation can be maintained.

Since Breyanzi addresses an unmet medical need, it benefitted from support within the PRIME scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines.

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