Difference between revisions of "Asparaginase erwinia chrysanthemi-rywn (Rylaze)"
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<br>Extravasation: n/a | <br>Extravasation: n/a | ||
| − | For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as | + | For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, UpToDate Lexidrug, [http://reference.medscape.com/drug/erwinaze-asparaginase-erwinia-chrysanthemi-999704 Medscape], or the prescribing information. |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
| Line 13: | Line 13: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | * 2021-06-30: Approved as a component of a multi-agent chemotherapeutic regimen for the treatment of [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL)]] in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase. ''(Based on COG AALL1931)'' |
| + | * 2022-11-18: Approved a new Monday-Wednesday-Friday dosing regimen. Under the new regimen, patients should receive 25 mg/m<sup>2</sup> intramuscularly on Monday and Wednesday mornings, and 50 mg/m<sup>2</sup> intramuscularly on Friday afternoon. ''(Based on COG AALL1931)'' | ||
| + | |||
| + | ==History of changes in EMA indication== | ||
| + | *2023-09-22: Granted marketing authorization as Enrylaze. Enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of [[:Category:Acute lymphoblastic leukemias|acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL)]] in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase. ''(Based on COG AALL1931)'' | ||
==Also known as== | ==Also known as== | ||
| + | *'''Code name:''' JZP-458 | ||
*'''Generic names:''' recombinant crisantaspasum, recombinant crisantaspase, recombinant Erwinia L-asparginase, recombinant krisantaspaasi, recombinant krisantaspas | *'''Generic names:''' recombinant crisantaspasum, recombinant crisantaspase, recombinant Erwinia L-asparginase, recombinant krisantaspaasi, recombinant krisantaspas | ||
| − | *'''Brand names:''' Rylaze | + | *'''Brand names:''' Enrylaze, Rylaze |
==References== | ==References== | ||
| + | #'''COG AALL1931:''' Maese L, Loh ML, Choi MR, Lin T, Aoki E, Zanette M, Agarwal S, Iannone R, Silverman JA, Silverman LB, Raetz EA, Rau RE. Recombinant Erwinia asparaginase (JZP458) in acute lymphoblastic leukemia: results from the phase 2/3 AALL1931 study. Blood. 2023 Feb 16;141(7):704-712. [https://doi.org/10.1182/blood.2022016923 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc10651770/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/36108304/ PubMed] [https://clinicaltrials.gov/study/NCT04145531 NCT04145531] | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Intramuscular medications]] | [[Category:Intramuscular medications]] | ||
| + | [[Category:Recombinant medications]] | ||
| − | [[Category: | + | [[Category:Asparagine-specific enzymes]] |
[[Category:B-cell acute lymphoblastic leukemia medications]] | [[Category:B-cell acute lymphoblastic leukemia medications]] | ||
| Line 30: | Line 37: | ||
[[Category:FDA approved in 2021]] | [[Category:FDA approved in 2021]] | ||
| + | [[Category:EMA approved in 2023]] | ||
Latest revision as of 01:29, 6 July 2024
Note: this is a recombinant product which is essentially identical to Asparaginase Erwinia chrysanthemi (Erwinaze). It is not a biosimilar.
General information
Class/mechanism: Depletes plasma asparagine by catalyzing the deamidation of asparagine to
aspartic acid and ammonia, selectively killing leukemic cells which are unable to synthesize asparagine due to a lack of asparagine synthetase.
Route: IM
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias such as Micromedex, UpToDate Lexidrug, Medscape, or the prescribing information.
Diseases for which it is used
History of changes in FDA indication
- 2021-06-30: Approved as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase. (Based on COG AALL1931)
- 2022-11-18: Approved a new Monday-Wednesday-Friday dosing regimen. Under the new regimen, patients should receive 25 mg/m2 intramuscularly on Monday and Wednesday mornings, and 50 mg/m2 intramuscularly on Friday afternoon. (Based on COG AALL1931)
History of changes in EMA indication
- 2023-09-22: Granted marketing authorization as Enrylaze. Enrylaze is indicated as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL) in adult and paediatric patients (1 month and older) who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase. (Based on COG AALL1931)
Also known as
- Code name: JZP-458
- Generic names: recombinant crisantaspasum, recombinant crisantaspase, recombinant Erwinia L-asparginase, recombinant krisantaspaasi, recombinant krisantaspas
- Brand names: Enrylaze, Rylaze
References
- COG AALL1931: Maese L, Loh ML, Choi MR, Lin T, Aoki E, Zanette M, Agarwal S, Iannone R, Silverman JA, Silverman LB, Raetz EA, Rau RE. Recombinant Erwinia asparaginase (JZP458) in acute lymphoblastic leukemia: results from the phase 2/3 AALL1931 study. Blood. 2023 Feb 16;141(7):704-712. link to original article link to PMC article PubMed NCT04145531