Lisocabtagene maraleucel
Gene therapy | |
---|---|
Target gene | CD19 |
Clinical data | |
Trade names | Breyanzi |
Other names | JCAR017 |
License data | |
Routes of administration | Intravenous |
Drug class | Antineoplastic |
ATC code |
|
Legal status | |
Legal status | |
Identifiers | |
UNII | |
KEGG | |
ChEMBL |
Lisocabtagene maraleucel (LM), sold under the brand name Breyanzi, is a CAR-T 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]
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[]
- ^ "Breyanzi- lisocabtagene maraleucel kit". DailyMed. Retrieved 29 March 2021.
- ^ Jump up to: a b c d "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.
- ^ Jump up to: a b c d e f g h i j k l "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.
- ^ 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.
External links[]
- "Lisocabtagene maraleucel". NCI Drug Dictionary. National Cancer Institute.
- Clinical trial number NCT02631044 for "Study Evaluating the Safety and Pharmacokinetics of JCAR017 in B-cell Non-Hodgkin Lymphoma (TRANSCEND-NHL-001)" at ClinicalTrials.gov
- "In potential big step, Bristol says CAR-T outperformed stem cell transplant". STAT. 10 June 2021. Retrieved 11 June 2021.
- Drugs not assigned an ATC code
- Breakthrough therapy
- Cancer treatments
- Gene therapy
- Orphan drugs