Difference between revisions of "Lisocabtagene maraleucel (Breyanzi)"
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*6/24/2022: Approved for adult patients with [[Diffuse large B-cell lymphoma|large B-cell lymphoma (LBCL)]] who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy. ''(Based on TRANSFORM)'' | *6/24/2022: Approved for adult patients with [[Diffuse large B-cell lymphoma|large B-cell lymphoma (LBCL)]] who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy. ''(Based on TRANSFORM)'' | ||
*6/24/2022: Approved for adult patients with [[Diffuse large B-cell lymphoma|large B-cell lymphoma (LBCL)]] who have refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age. ''(Based on TRANSFORM)'' | *6/24/2022: Approved for adult patients with [[Diffuse large B-cell lymphoma|large B-cell lymphoma (LBCL)]] who have refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age. ''(Based on TRANSFORM)'' | ||
| − | + | ==History of changes in EMA indication== | |
| + | *4/4/2022: Breyanzi is indicated for the treatment of adult patients with relapsed or refractory [[Diffuse large B-cell lymphoma|diffuse large B-cell lymphoma (DLBCL)]], [[Primary mediastinal B-cell lymphoma|primary mediastinal large B-cell lymphoma (PMBCL)]] and follicular lymphoma grade 3B (FL3B), after two or more lines of systemic therapy. | ||
== Patient Drug Information== | == Patient Drug Information== | ||
*[https://www.fda.gov/media/145711/download Lisocabtagene maraleucel (Breyanzi) Package Insert]<ref>[https://www.fda.gov/media/145711/download Lisocabtagene maraleucel (Breyanzi) Package Insert]</ref> | *[https://www.fda.gov/media/145711/download Lisocabtagene maraleucel (Breyanzi) Package Insert]<ref>[https://www.fda.gov/media/145711/download Lisocabtagene maraleucel (Breyanzi) Package Insert]</ref> | ||
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[[Category:REMS program]] | [[Category:REMS program]] | ||
[[Category:FDA approved in 2021]] | [[Category:FDA approved in 2021]] | ||
| + | [[Category:EMA approved in 2022]] | ||
[[Category:Bristol-Myers Squibb product]] | [[Category:Bristol-Myers Squibb product]] | ||
Revision as of 02:45, 4 February 2023
Mechanism of action
From the NCI Drug Dictionary: A preparation of a defined ratio of CD4+ and CD8+ autologous T lymphocytes transduced with a lentiviral vector expressing a chimeric antigen receptor (CAR) containing an anti-CD19 single chain variable fragment (scFv) fused to the signaling domain of 4-1BB (CD137), the zeta chain of the TCR/CD3 complex (CD3-zeta), and a truncated form of the human epidermal growth factor receptor (EGFRt), with potential immunostimulating and antineoplastic activities. Upon intravenous administration, lisocabtagene maraleucel is directed to and induce selective toxicity in CD19-expressing tumor cells.
Toxicity management
Diseases for which it is established (work in progress)
- Diffuse large B-cell lymphoma
- High-grade B-cell lymphoma
- Primary mediastinal B-cell lymphoma
- Transformed lymphoma
History of changes in FDA indication
- 2/5/2021: Approved for the treatment of adult patients with relapsed or refractory (R/R) 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. (Based on TRANSCEND NHL-001)
- 6/24/2022: Approved for adult patients with large B-cell lymphoma (LBCL) who have refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy. (Based on TRANSFORM)
- 6/24/2022: Approved for adult patients with large B-cell lymphoma (LBCL) who have refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age. (Based on TRANSFORM)
History of changes in EMA indication
- 4/4/2022: Breyanzi is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), after two or more lines of systemic therapy.
Patient Drug Information
Also known as
- Code name: JCAR017
- Brand names: Breyanzi, Liso-cel
References
Categories:
- Chimeric antigen receptor T-cells
- Anti-CD3 cellular therapy
- Anti-CD19 cellular therapy
- Anti-CD137 cellular therapy
- Intravenous medications
- Diffuse large B-cell lymphoma medications
- Primary mediastinal B-cell lymphoma medications
- Transformed lymphoma medications
- REMS program
- FDA approved in 2021
- EMA approved in 2022
- Bristol-Myers Squibb product