L-asparaginase, a key component in the treatment of acute lymphoblastic leukemia (ALL), is an enzyme that depletes the amino acid asparagine, which certain leukemic cells are dependent upon for survival.
Oncaspar allows patients to gain the full benefits of asparaginase therapy with enhanced patient convenience over native L-asparaginase (nonPEGylated form).
Through the process of pegylation, the half-life of L-asparaginase is significantly increased and the L-asparaginase activity is sustained.
The approval to manufacture L-asparaginase came after the previous supplier decided to cease production, leading to a three-year development effort to create a comparable active ingredient.
Sigma-Tau said the approval averts a potentially dangerous drug shortage situation in the US which could have affected thousands of patients with ALL.