New formulation of Oncaspar receives Marketing Authorization in Europe for patients with ALL

Freeze-dried, or lyophilized, formulation aims to improve supply management by providing the same dosing regimen as liquid Oncaspar but with a three-times longer shelf life of up to 24 months.

“This approval underscores Shire’s commitment to patients with acute lymphoblastic leukemia through continued research and evolution of asparaginase therapy,” said Howard B. Mayer, SVP and ad-interim Head, Global Research and Development, Shire. “With this lyophilized formulation, we aim to make pegylated asparaginase, part of the pediatric standard therapy in acute lymphoblastic leukemia, available to patients in countries where liquid Oncaspar is not currently offered. 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.”

Lyophilized Oncaspar builds on more than a decade of data and research with liquid Oncaspar, a pegylated asparaginase, and works the same way as the liquid formulation. By depleting serum L-asparagine levels and thereby interfering with protein synthesis, Oncaspar deprives lymphoblasts of L-asparagine, resulting in cell death.

The new lyophilized formulation offers the same dosing regimen as liquid Oncaspar, but with a three-times longer shelf life than the liquid formulation. Asparaginase is a critical component of the treatment regimen for ALL patients as it is a proven approach to inducing leukemic cell death.

Shire expects lyophilized Oncaspar to be available in European markets beginning in the first half of 2018.