Jazz Pharmaceuticals gets Rylaze FDA approval for ALL and LBL
Rylaze FDA approval : Jazz Pharmaceuticals has secured approval for its leukemia drug Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn or JZP458) from the US Food and Drug Administration (FDA).
The Irish biopharma company bagged the approval for the drug to be used as a component of a multi-agent chemotherapeutic regimen for the treatment of acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LBL). The approval is for the treatment of pediatric and adults, one month and older in whom hypersensitivity has been developed to E. coli-derived asparaginase.
According to Jazz Pharmaceuticals, Rylaze is the only recombinant erwinia asparaginase manufactured product that sustains a clinically meaningful level of asparaginase activity right through the full duration of treatment.
Commenting on Rylaze FDA approval, Bruce Cozadd – chairman and CEO of Jazz Pharmaceuticals said: “We are excited to bring this important new treatment to patients who are in critical need, and we are grateful to FDA for the approval of Rylaze based on its established safety and efficacy profile.
“We are pleased Rylaze was approved before the trial is complete and are diligently working to advance additional clinical trial data. We are committed to quickly engaging with FDA to evolve the Rylaze product profile with additional dosing options and an IV route of administration.”
Jazz Pharmaceuticals obtains FDA Rylaze endorsement for lymphoblastic leukemia or lymphoblastic lymphoma. Photo courtesy of Jazz Pharmaceuticals plc.
Rylaze FDA approval was driven by the findings from the first of three intramuscular (IM) cohorts of an ongoing phase 2/3 single-arm, open-label, multicenter, dose confirmation study.
The clinical trial is assessing Rylaze in pediatric and adult patients with ALL or LBL who have had an allergic reaction to E. coli-derived asparaginases and previously did not get asparaginase erwinia chrysanthemi.
In the cohorts, the achievement and maintenance of nadir serum asparaginase activity (NSAA) were shown to be more or equal to the level of 0.1 U/mL at 48 hours using IM doses of Rylaze 25 mg/m.
Jazz Pharmaceuticals said that the results of modeling and simulations demonstrated that for a dosage of 25 mg/m2 intramuscularly administered every 48 hours, the percentage of patients who could maintain NSAA ≥ 0.1 U/mL at 48 hours after a dose of Rylaze was 93.6%.