The US Food and Drug Administration has approved Dublin-based Jazz Pharmaceutical’s Rylaze for the treatment of two blood cancers – acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL).
The FDA approval clears Rylaze (asparaginase erwinia chrysanthemi) for use as a component of a multi-agent chemotherapeutic regimen for the treatment of ALL or LBL in paediatric and adult patients aged one month and older, who have hypersensitivity to E.coli-derived asparaginase.
The US green light is based on data from an ongoing Phase II/III study evaluating paediatric and adult patients with ALL or LBL who have had an allergic reaction to E.coli-derived asparaginases and have not previously received asparaginase erwinia chrysanthemi.
Data from the first of three intramuscular (IM) route of administration cohorts demonstrated the achievement and maintenance of nadir serum asparaginase activity (NSAA) greater than or equal to the level of 0.1 U/mL at 48 hours using IM doses of Rylaze 25 mg/m.
In a statement, Jazz said Rylaze is the only recombinant erwinia asparaginase manufactured product that maintains a clinically meaningful level of asparaginase activity throughout the entire duration of treatment.
“The accelerated development and approval of Rylaze marks an important step in bringing a meaningful new treatment option for many ALL patients – most of whom are children – who cannot tolerate E. coli-derived asparaginase medicine,” said Luke Maese, assistant professor at the University of Utah, Primary Children’s Hospital and Huntsman Cancer Institute in the US.
“Before the approval of Rylaze, there was a significant need for an effective asparaginase medicine that would allow patients to start and complete their prescribed treatment program with confidence in supply,” he added.
