FDA Approves Alternate Dosing Schedule for Rylaze

Rylaze’s dosing options provide sustained asparaginase activity throughout the entire course of treatment for adult and pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.

The FDA has approved Jazz Pharmaceuticals’ biologics license application (sBLA) for an additional dosing regimen for Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) to treat acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adults and children who have developed hypersensitivity to E. coli-derived asparaginase.

Rylaze was initially approved in July 2021 as administration every 48 hours. This approval adds a Monday/Wednesday/Friday intramuscular dosing schedule. At the time of it launch last year, Rylaze’s wholesale acquisition price was $4,390 per vial.

“The expansion of the Rylaze label to include a Monday/Wednesday/Friday dosing schedule provides another option to support patients in completing their planned asparaginase treatment regimen. The benefit of completing the full course of asparaginase has been shown in various publications, and discontinuation of asparaginase has been associated with inferior disease-free survival,” said Luke Maese, D.O., associate professor at the University of Utah, Primary Children's Hospital and Huntsman Cancer Institute.

The new dosing option was based on data from the intramuscular administration part of the phase 2/3 trial. Results show that a dosing regimen of 25 mg/m2 administered intramuscularly on Monday morning and Wednesday morning, and 50 mg/m2 administered on Friday afternoon demonstrated a positive benefit-to-risk profile, with more than 90% of the patients achieving nadir serum asparaginase activity. No new safety signals observed in the trial.

Related: NCCN Adds Jazz’s ALL Therapy Rylaze to Practice Guidelines

Rylaze is a recombinant Erwinia asparaginase that uses a novel Pseudomonas fluorescens expression platform for production. It is indicated for those patients who have developed hypersensitivity to E. coli-derived asparaginase. Rylaze works depletes plasma asparagine in cancer cells. Cells need asparagine to make proteins and reproduce. Unlike normal cells, ALL cells are unable to make their own asparagine.