Lisocabtagene maraleucel

Lisocabtagene maraleucel (LM), sold under the brand name Breyanzi, is a CAR-T therapy used to treat large B-cell lymphoma.[2][3]

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

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

LM 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] LM was approved for medical use in the United States in February 2021.[2][3]

Medical uses

LM 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]

LM 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

LM'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 FDA granted LM orphan drug, regenerative medicine advanced therapy (RMAT) and breakthrough therapy designations.[3] LM 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]

Culture

Names

LM is the international nonproprietary name (INN).[4]

References
  1. "Breyanzi- lisocabtagene maraleucel kit". DailyMed. Retrieved 29 March 2021.
  2. "Lisocabtagene maraleucel". U.S. Food and Drug Administration (FDA). 5 February 2021. Retrieved 5 February 2021. This article incorporates text from this source, which is in the public domain.
  3. "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. This article incorporates text from this source, which is in the public domain.
  4. 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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