U.S FDA Approves a New Intramuscular Dosing Regimen for Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)

On November 18, 2022, the U.S. FDA approved a new Monday/Wednesday/Friday (MWF) intramuscular (IM) dosing schedule for asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze, Jazz Pharmaceuticals).

According to this new regimen, patients should receive 25 mg/m2 intramuscularly on Monday and Wednesday mornings, and 50 mg/m2 intramuscularly on Friday afternoon. This medicine can also be administered every 48 hours at a dose of 25 mg/m2 intramuscularly.

Rylaze is approved by the FDA in June 2021 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 aged 30 days or older who have developed hypersensitivity to E. coli-derived asparaginase.

Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharma stated, “With the addition of a MWF (Monday/Wednesday/Friday) dosing schedule for Rylaze (asparaginase erwinia chrysanthemi-rywn), patients will have another availability of dosing, which help provide sustained asparaginase activity throughout the entire course of treatment.”

Outcomes demonstrates that a dosing regimen of 25 mg/m2 given intramuscularly on Monday and Wednesday morning, and 50 mg/m2 given on Friday afternoon demonstrated a positive benefit-to-risk profile, with ≥90% of the patients achieving nadir serum asparaginase activity (NSAA) ≥0.1 U/mL by simulation.

Overall, the safety profile of Rylaze (asparaginase erwinia chrysanthemi-rywn) was persistent with the reported safety deets for patients with Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) receiving asparaginase with combination chemotherapy. There were no new safety signals noted in the trial.

Rylaze (asparaginase erwinia chrysanthemi-rywn) was granted orphan drug designation for Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL) in June 2021 and was added to the NCCN Guidelines in July 2021.

About Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn):
Rylaze, also named JZP458, is authorized in the United States for use as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients aged 1-month or older who have developed hypersensitivity to E. coli-derived asparaginase.
Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) has orphan drug designation for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in the US.
Rylaze is widely known as an promising and reliable treatment option for those with ALL and LBL that have developed hypersensitivity to an E. coli-derived asparaginase.
JZP458 (Rylaze) was granted Fast Track designation by the U.S. FDA in October 2019 to treat this patient population. This medicinal product was approved as part of the RTOR program, an initiative of the FDA’s Oncology Center of Excellence designed for the efficient delivery of safe and effective cancer treatments to patients.

Reference: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-new-dosing-regimen-asparaginase-erwinia-chrysanthemi-recombinant?utm_medium=email&utm_source=govdelivery