The Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Oncaspar, intended for the treatment of acute lymphoblastic leukaemia.
Oncaspar was authorised in 1994 in Germany and in 2008 in Poland for the treatment of patients with acute lymphoblastic leukaemia who were hypersensitive to native forms of asparaginase.

Oncaspar is available as a 750 U/ml solution for injection or infusion. The active substance of Oncaspar is Pegaspargase, an antineoplastic agent.

Pegaspargase is obtained by PEGylation of the asparaginase enzyme. The mechanism of action of asparaginase is the enzymatic degradation of the amino acid asparagine. Depletion of asparagine in blood serum results in apoptosis of cells highly dependent on asparagine, especially leukaemic blasts.
The PEGylation does not change the enzymatic properties of Asparaginase, but it prolongs the half-life of Asparaginase and reduces its immunogenicity.

Consequent to the complete asparagine depletion in serum, the benefit with Oncaspar administered as part of combination chemotherapy is its ability to increase the proportion of patients who have complete remission at the end of the treatment period.
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.

The full indication is: Oncaspar is indicated as a component of antineoplastic combination therapy in acute lymphoblastic leukaemia ( ALL ) in paediatric patients from birth to 18 years, and adult patients. ( Xagena )

Source: EMA, 2015

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