The European Commission (EC) has granted marketing authorisation for Jazz Pharmaceuticals’ Enrylaze as part of a multi-agent regimen for acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL).
The treatment is approved in adult and paediatric patients who developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.
Enrylaze, approved as Rylaze in the United States and Canada, is a new Erwinia-derived asparaginase developed using a next-generation recombinant technology with a safety profile consistent with that of other asparaginase preparations.
“Asparaginase is a core component of multi-agent chemotherapeutic regimens for the treatment of ALL, however, up to 30% of patients develop hypersensitivity to E. coli-derived asparaginase, resulting in a delay or disruption in treatment,” said Professor Carmelo Rizzari, Department of Pediatrics, University of Milano-Bicocca, Head of the Pediatric Hematology Oncology Unit, Foundation IRCCS San Gerardo dei Tintori, Monza, Italy.
“The ability to complete a full course of asparaginase treatment is of critical importance when treating ALL and LBL, as it is strongly linked to improved outcomes for patients. The approval of Enrylaze now provides an important option to support patients in completing their planned asparaginase treatment regimen.”
The EC approval is based on data from a Phase II/III trial conducted in collaboration with the Children’s Oncology Group (COG) in a cohort of 228 paediatric and adult patients with ALL and LBL who have developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.
The determination of efficacy was based on nadir serum asparaginase activity (NSAA) levels ≥ 0.1 U/mL. The proportion of patients achieving this at 48 hours after an IV dose was 89.8% and 40% at 72 hours post-dose. The IM administration achieved sustained NSAA in 95.9% of patients at 48 hours after a dose and 89.8% of patients at 72 hours post-dose.