Lisocabtagene maraleucel

Lisocabtagene maraleucel
Gene therapy
Target geneCD19
Clinical data
Trade namesBreyanzi
Other namesJCAR017, LM
License data
Routes of
administration		Intravenous
Drug classAntineoplastic
ATC code
  • None
Legal status
Legal status
Identifiers
DrugBank
UNII
KEGG
ChEMBL

Lisocabtagene maraleucel, sold under the brand name Breyanzi, is a cell-based gene therapy used to treat large B-cell lymphoma.[2][3]

Side effects include hypersensitivity reactions, serious infections, low blood cell counts, and a weakened immune system.[3]

Lisocabtagene maraleucel, a chimeric antigen receptor (CAR) T cell (CAR-T) therapy, is the third gene therapy approved by the U.S. Food and Drug Administration (FDA) for certain types of non-Hodgkin lymphoma, including diffuse large B-cell lymphoma (DLBCL).[3] Lisocabtagene maraleucel was approved for medical use in the United States in February 2021.[2][3]

Medical uses

Lisocabtagene maraleucel is indicated for the treatment of adults with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B.[2][3]

Lisocabtagene maraleucel is not indicated for the treatment of people with primary central nervous system lymphoma.[3]

Adverse effects

The labeling carries a boxed warning for cytokine release syndrome (CRS), which is a systemic response to the activation and proliferation of CAR-T cells, causing high fever and flu-like symptoms and neurologic toxicities.[3]

History

Lisocabtagene maraleucel's safety and efficacy were established in a multicenter clinical trial of more than 250 adults with refractory or relapsed large B-cell lymphoma.[3] The complete remission rate after treatment was 54%.[3]

The U.S. Food and Drug Administration (FDA) granted lisocabtagene maraleucel orphan drug, regenerative medicine advanced therapy (RMAT), and breakthrough therapy designations.[3] Lisocabtagene maraleucel is the first regenerative medicine therapy with RMAT designation to be licensed by the FDA.[3] The FDA granted approval of Breyanzi to Juno Therapeutics Inc., a Bristol-Myers Squibb Company.[3]

Society and culture

On 27 January 2022, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product 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.[4][5] The applicant for this medicinal product is Bristol-Myers Squibb Pharma EEIG.[4]

Names

Lisocabtagene maraleucel is the international nonproprietary name (INN).[6]

References

  1. ↑ "Breyanzi- lisocabtagene maraleucel kit". DailyMed. Retrieved 29 March 2021.
  2. 1 2 3 4 "Lisocabtagene maraleucel". U.S. Food and Drug Administration (FDA). 5 February 2021. Retrieved 5 February 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  3. 1 2 3 4 5 6 7 8 9 10 11 12 "FDA Approves New Treatment For Adults With Relapsed Or Refractory Large-B-Cell Lymphoma". U.S. Food and Drug Administration (FDA) (Press release). 5 February 2021. Retrieved 5 February 2021. Public Domain This article incorporates text from this source, which is in the public domain.
  4. 1 2 "Breyanzi: Pending EC decision". European Medicines Agency (EMA). 28 January 2022. Retrieved 28 January 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  5. ↑ "New gene therapy treatment for patients with relapsed or refractory large B-cell lymphoma" (Press release). European Medicines Agency (EMA). 27 January 2022. Retrieved 28 January 2022.
  6. ↑ World Health Organization (2019). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 81". WHO Drug Information. 33 (1): 82-3. hdl:10665/330896.
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