Difference between revisions of "Lisocabtagene maraleucel (Breyanzi)"
Jump to navigation
Jump to search
m |
m |
||
| (8 intermediate revisions by the same user not shown) | |||
| Line 5: | Line 5: | ||
*[https://www.breyanzirems.com Link to REMS program] | *[https://www.breyanzirems.com Link to REMS program] | ||
| − | ==Diseases for which it is established | + | ==Diseases for which it is established== |
*[[Diffuse large B-cell lymphoma]] | *[[Diffuse large B-cell lymphoma]] | ||
*[[High-grade B-cell lymphoma]] | *[[High-grade B-cell lymphoma]] | ||
| + | *[[Mantle cell lymphoma]] | ||
*[[Primary mediastinal B-cell lymphoma]] | *[[Primary mediastinal B-cell lymphoma]] | ||
*[[Transformed lymphoma]] | *[[Transformed lymphoma]] | ||
| + | ==Diseases for which it is used== | ||
| + | *[[Chronic lymphocytic leukemia]] | ||
| + | *[[Follicular lymphoma]] | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2024-05-15: Granted accelerated approval for adults with relapsed or refractory [[Follicular lymphoma|follicular lymphoma (FL)]] who have received two or more prior lines of systemic therapy. ''(Based on TRANSCEND-FL)'' |
| − | * | + | *2021-02-05: 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|diffuse large B-cell lymphoma (DLBCL) not otherwise specified]] (including [[Transformed lymphoma|DLBCL arising from indolent lymphoma]]), [[high-grade B-cell lymphoma]], [[Primary mediastinal B-cell lymphoma|primary mediastinal large B-cell lymphoma]], and follicular lymphoma grade 3B. ''(Based on TRANSCEND NHL-001)'' |
| − | * | + | *2022-06-24: 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)'' |
| + | *2022-06-24: 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)'' | ||
| + | *2024-05-30: Approved for adult patients with relapsed or refractory [[mantle cell lymphoma|mantle cell lymphoma (MCL)]] who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor (BTKi). ''(Based on TRANSCEND-MCL)'' | ||
| + | |||
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
| − | * | + | *2022-04-04: 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. |
| + | *2023-05-25: Revised indication for the treatment of adult patients with [[Diffuse large B-cell lymphoma|diffuse large B-cell lymphoma (DLBCL)]], [[High-grade B-cell lymphoma|high grade B-cell lymphoma (HGBCL)]], [[Primary mediastinal B-cell lymphoma|primary mediastinal large B-cell lymphoma (PMBCL)]] and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy. | ||
| + | |||
| + | ==History of changes in Health Canada indication== | ||
| + | *2022-05-06: Initial notice of compliance | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2021-03-22: Initial approval | ||
== 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> | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code name:''' | + | *'''Code name:''' JCAR-017 |
| − | *'''Brand | + | *'''Generic name:''' liso-cel |
| + | *'''Brand name:''' Breyanzi | ||
==References== | ==References== | ||
| − | [[Category: | + | [[Category:Anti-CD19 CAR T-cells]] |
[[Category:Anti-CD3 cellular therapy]] | [[Category:Anti-CD3 cellular therapy]] | ||
[[Category:Anti-CD19 cellular therapy]] | [[Category:Anti-CD19 cellular therapy]] | ||
| Line 33: | Line 47: | ||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| + | [[Category:Chronic lymphocytic leukemia medications]] | ||
[[Category:Diffuse large B-cell lymphoma medications]] | [[Category:Diffuse large B-cell lymphoma medications]] | ||
| + | [[Category:Follicular lymphoma medications]] | ||
| + | [[Category:High-grade B-cell lymphoma medications]] | ||
| + | [[Category:Mantle cell lymphoma medications]] | ||
[[Category:Primary mediastinal B-cell lymphoma medications]] | [[Category:Primary mediastinal B-cell lymphoma medications]] | ||
[[Category:Transformed lymphoma medications]] | [[Category:Transformed lymphoma medications]] | ||
| Line 40: | Line 58: | ||
[[Category:FDA approved in 2021]] | [[Category:FDA approved in 2021]] | ||
[[Category:EMA approved in 2022]] | [[Category:EMA approved in 2022]] | ||
| + | [[Category:Health Canada approved in 2022]] | ||
| + | [[Category:PMDA approved in 2021]] | ||
[[Category:Bristol-Myers Squibb product]] | [[Category:Bristol-Myers Squibb product]] | ||
Revision as of 03:31, 1 June 2024
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
- Diffuse large B-cell lymphoma
- High-grade B-cell lymphoma
- Mantle cell lymphoma
- Primary mediastinal B-cell lymphoma
- Transformed lymphoma
Diseases for which it is used
History of changes in FDA indication
- 2024-05-15: Granted accelerated approval for adults with relapsed or refractory follicular lymphoma (FL) who have received two or more prior lines of systemic therapy. (Based on TRANSCEND-FL)
- 2021-02-05: 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)
- 2022-06-24: 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)
- 2022-06-24: 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)
- 2024-05-30: Approved for adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least two prior lines of systemic therapy, including a Bruton tyrosine kinase inhibitor (BTKi). (Based on TRANSCEND-MCL)
History of changes in EMA indication
- 2022-04-04: 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.
- 2023-05-25: Revised indication for the treatment of adult patients with diffuse large B-cell lymphoma (DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B), who relapsed within 12 months from completion of, or are refractory to, first-line chemoimmunotherapy.
History of changes in Health Canada indication
- 2022-05-06: Initial notice of compliance
History of changes in PMDA indication
- 2021-03-22: Initial approval
Patient Drug Information
Also known as
- Code name: JCAR-017
- Generic name: liso-cel
- Brand name: Breyanzi
References
Categories:
- Anti-CD19 CAR T-cells
- Anti-CD3 cellular therapy
- Anti-CD19 cellular therapy
- Anti-CD137 cellular therapy
- Intravenous medications
- Chronic lymphocytic leukemia medications
- Diffuse large B-cell lymphoma medications
- Follicular lymphoma medications
- High-grade B-cell lymphoma medications
- Mantle cell lymphoma medications
- Primary mediastinal B-cell lymphoma medications
- Transformed lymphoma medications
- REMS program
- FDA approved in 2021
- EMA approved in 2022
- Health Canada approved in 2022
- PMDA approved in 2021
- Bristol-Myers Squibb product