Asparaginase erwinia chrysanthemi-rywn (Rylaze)

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, Lexicomp, Medscape, UpToDate (courtesy of Lexicomp), 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 PubMed NCT04145531