Sign Up Now!
To sign up for our newsletter or print publications, please enter your contact information below.
First Name *
Last Name *
Email Address (Verify) *
We will request your mailing address on the next page.
We will request your mailing address on the next page.

Rylaze FDA Approved as Part of a Treatment Regimen for Pediatric Leukemia and Lymphoma

JHOP - August 2021 Vol 11, No 4 - FDA Updates
Download PDF

On June 30, 2021, the FDA accelerated the approval of asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze; Jazz Pharmaceuticals), an asparagine-specific enzyme, as a component of a multidrug chemotherapy regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma in patients aged ≥1 months with hypersensitivity to Escherichia coli–derived asparaginase.

The FDA granted erwinia chrysanthemi an orphan drug designation for this indication. Erwinia chrysanthemi will address the shortages of Erwinia asparaginase (Erwinaze). Rylaze “has the same molecular makeup as Erwinaze. But it’s manufactured differently, and in a more efficient way, so having the option to substitute Rylaze should reduce the likelihood of treatment shortages for these patients in the future,” said Malcolm A. Smith, MD, PhD, Associate Branch Chief for Pediatric Oncology, NCI’s Cancer Therapy Evaluation Program.

Erwinia chrysanthemi can be used as a substitute to Erwinia asparaginase in people with an immune reaction to pegaspargase. These ongoing shortages have been “incredibly stressful to patients and their parents,” said Sumit Gupta, MD, PhD, University of Toronto, and Pediatric Oncologist, Hospital for Sick Children, Toronto, Canada.

The FDA approved erwinia chrysanthemi based on results of an open-label, multicohort, multicenter clinical trial of 102 patients (median age, 10 years; range, 1-24 years) with ALL or lymphoblastic lymphoma and hypersensitivity to asparaginase caused by E coli infection, as part of a multidrug chemotherapy regimen.

The primary end point was achievement and maintenance of nadir serum asparaginase activity (NSAA) >0.1 U/mL. The results of modeling and simulations showed that for a dosage of 25 mg/m2 administered every 48 hours, the proportion of patients maintaining NSAA ≥0.1 U/mL at 48 hours after a dose of erwinia chrysanthemi was 93.6% (95% confidence interval, 92.6%-94.6%).

The most common (>20%) adverse reactions were abnormal liver test, nausea, musculoskeletal pain, fatigue, infection, headache, pyrexia, drug hypersensitivity, febrile neutropenia, decreased appetite, stomatitis, bleeding, and hyperglycemia.

Related Items
Tivdak First Antibody–Drug Conjugate FDA Approved for Recurrent or Metastatic Cervical Cancer
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Exkivity Novel Oral Targeted Therapy Approved for Metastatic NSCLC with EGFR Exon 20 Insertion Mutations
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Welireg FDA Approved for 3 Tumor Types Associated with von Hippel-Lindau Disease
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Rezurock Novel Oral Therapy FDA Approved for Chronic Graft-Versus-Host Disease
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Jakafi a New Treatment Option for Chronic Graft-Versus-Host Disease
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Cabometyx Receives FDA Approval for Differentiated Thyroid Cancer
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Brukinsa Approved for Marginal-Zone Lymphoma and for Waldenström’s Macroglobulinemia
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Nivolumab First Immunotherapy Approved for Adjuvant Treatment of Urothelial Carcinoma
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Jemperli Another Therapy Approved for Patients with dMMR Recurrent or Advanced Solid Tumors
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Lenvima plus Keytruda a New Combination Approved for Advanced Renal-Cell Carcinoma
JHOP - October 2021 Vol 11, No 5 published on October 14, 2021 in FDA Updates
Copyright © Green Hill Healthcare Communications, LLC. All rights reserved.