The EC approval was based on findings from the Phase 2/3 trial conducted in collaboration with the Children’s Oncology Group (COG) in a group of 228 paediatric and adult patients
Jazz Pharma’s Enrylaze secures approval in Europe. (Credit: fernando zhiminaicela from Pixabay)
Jazz Pharmaceuticals, a partner of Ligand Pharmaceuticals, has secured marketing authorisation from the European Commission (EC) for Enrylaze (JZP458) to treat acute lymphoblastic leukaemia (ALL) and lymphoblastic lymphoma (LBL).
Enrylaze, approved as Rylaze in the US and Canada, is said to be the only recombinant Erwinia asparaginase or crisantaspase. It is derived from a Pseudomonas fluorescens expression platform.
EC has approved Enrylaze for use as a component of a multi-agent chemotherapeutic regimen to treat ALL and LBL in adult and paediatric patients (one month and older) who have developed hypersensitivity or silent inactivation to E. coli-derived asparaginase.
The EC approval was based on findings from the Phase 2/3 trial conducted in collaboration with the Children’s Oncology Group (COG) in a group of 228 paediatric and adult patients.
It was conducted in two parts in which the first part investigated the intramuscular (IM) route of administration whereas the second part assessed the intravenous (IV) route of administration.
According to the results, for the IV administration of Enrylaze, 89.8% of patients maintained nadir serum asparaginase activity (NSAA) levels ≥ 0.1 U/mL at 48 hours and 40% at 72 hours post-dose.
The IM administration of Erwinia-derived asparaginase achieved sustained asparagine activity in 95.9% of patients at 48 hours after a dose and 89.8% of patients at 72 hours post-dose.
Overall, the safety profile of the drug was like reported safety information for patients with ALL/LBL receiving asparaginase with combination chemotherapy.
Ligand Pharmaceuticals CEO Todd Davis said: “We congratulate our partner Jazz on its receipt of approval for Enrylaze from the European Commission, expanding the market opportunity for one of our key commercial-stage products.
“Jazz has executed a successful launch of the product in the US, and we look forward to contributions from sales in the European Union.”
The Phase 2/3 single-arm, open-label, multicentre, dose confirmation study assessed the safety, tolerability, and efficacy of JZP458.
In December last year, Jazz exercised its option to continue with its exclusive rights to Zymeworks’ cancer drug candidate zanidatamab for $325m.