The US Food and Drug Administration (FDA) has approved Rylaze® (asparaginase erwinia chrysanthemi [recombinant]-rywn) to be administered on a Monday/Wednesday/Friday (MWF) intramuscular (IM) dosing schedule, in addition to a previously approved dosing regimen (25 mg/m2 IM every 48 hours).

Rylaze is indicated for use as part 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 of age and older who have developed hypersensitivity to E. coli-derived asparaginase.

The MWF dosing option was approved under the Real-Time Oncology Review pilot program based on pharmacokinetic data from the IM administration portion of a phase 2/3 study (AALL1931; ClinicalTrials.gov Identifier: NCT04145531). The trial was designed to assess the tolerability and efficacy of Rylaze at various dosages and routes of administration.


Continue Reading

Findings demonstrated a positive benefit-to-risk profile for a dosing regimen of 25 mg/m2 IM on Monday morning and Wednesday morning, and 50 mg/m2 on Friday afternoon. Efficacy was defined as achievement and maintenance of nadir serum asparaginase activity (NSAA) above the level of 0.1 U/mL by simulation in a virtual population. The analysis showed that more than 90% of patients achieved NSAA of at least 0.1 U/mL by simulation.

The safety profile of Rylaze was consistent with that observed for patients with ALL/LBL who receive asparaginase with chemotherapy (eg, neutropenia, anemia, or thrombocytopenia). There were no new safety signals observed.

References

  1. Jazz Pharmaceuticals announces US FDA approval of Monday/Wednesday/Friday intramuscular dosing schedule for Rylaze® (asparaginase erwinia chrysanthemi (recombinant)-rywn). News release. Jazz Pharmaceuticals. Accessed November 18, 2022. https://www.prnewswire.com/news-releases/jazz-pharmaceuticals-announces-us-fda-approval-of-mondaywednesdayfriday-intramuscular-dosing-schedule-for-rylaze-asparaginase-erwinia-chrysanthemi-recombinant-rywn-301683034.html
  2. Maese LD, Loh ML, Choi MR, et al. Efficacy and safety of intramuscular (IM) recombinant Erwinia asparaginase in acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL): The Children’s Oncology Group (COG) AALL1931 study. Published online June 2, 2022. Journal of Clinical Oncology. doi:10.1200/JCO.2022.40.16_suppl.7001
  3. Rylaze. Package insert. Jazz Pharmaceuticals; 2022. Accessed November 18, 2022. https://pp.jazzpharma.com/pi/rylaze.en.USPI.pdf

This article originally appeared on MPR