EU CHMP recommends approval of Oncaspar (pegaspargase) for acute lymphoblastic leukaemia- Medac

The CHMP recommended granting a marketing authorisation for Oncaspar (pegaspargase), from Medac, for the treatment of acute lymphoblastic leukaemia. It is indicated as a component of antineoplastic combination therapy in ALL in paediatric patients from birth to 18 years, and adult patients.

Oncaspar has shown to be effective when administered to patients non-hypersensitive to native forms of asparaginase as well as patients previously treated and hypersensitive to native forms of asparaginase. The most common side effects are hypersensitivity including anaphylactic reaction, febrile neutropenia, anaemia, hyperglycaemia, decreased platelet count, decreased neutrophil count and increased blood bilirubin.

Comment:Oncaspar (pegaspargase) is the only FDA-approved pegylated formulation of L-asparaginase, the enzyme that depletes the amino acid asparagine. For the last 25 years, L-asparaginase has been an important component in the treatment of acute lymphoblastic leukemia. While normal cells can produce asparagine, leukemic cells are unable to produce enough asparagine to survive on their own. L-asparaginase is given to ALL patients to ensure depletion of asparagine that is circulating in the blood. Depletion of asparagine ultimately results in leukemic cell death. 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.