European regulators have approved a new, freeze-dried formulation of Shire’s leukaemia therapy Oncaspar.
The drug is a component of antineoplastic combination therapy in acute lymphoblastic leukemia (ALL) in paediatric patients from birth to 18 years, and also in adult patients.
With a shelf-life three times longer than that of the drug in its liquid form, it is hoped that availability of freeze-dried, or lyophilized, Oncospar (pegaspargase) will improve inventory management and thus secure uninterrupted supply for patients.
The new lyophilized formulation also offers the same dosing regimen as the liquid Oncaspar, and should be available in European markets early next year.
“With this lyophilized formulation, we aim to make pegylated asparaginase, part of the paediatric standard therapy in acute lymphoblastic leukemia, available to patients in countries where liquid Oncaspar is not currently offered,” said Howard Mayer, ad-interim head of Global Research and Development, Shire.
“Additionally, with extended shelf life up to 24 months, treatment centers will have flexibility in inventory management to help ensure continuous treatment supply for patients.”
Oncaspar helps to induce cell death by depleting levels of serum L-asparagine levels, which interfere with protein synthesis.