ERWINASE (Erwinia L-asparaginase), antineoplastic agent
HAEMATOLOGY - New medicinal product
Opinions on drugs -
Posted on
Jan 28 2016
Reason for request
Inclusion
Minor improvement in the treatment of acute lymphoblastic leukaemia in, mainly paediatric, patients who have developed hypersensitivity to native or pegylated E. coli asparaginase
- For more than a decade, ERWINASE has been used in the setting of temporary usage authorisations (TUA). This proprietary medicinal product now has Marketing Authorisation in patients who have developed hypersensitivity (clinical allergy or silent inactivation) to:
- native E. coli asparaginase (KIDROLASE), which is recommended as first-line treatment in France
or
- pegylated E. coli asparaginase: no proprietary medicinal product of this type currently has Marketing authorisation in France. Only ONCASPAR is available in the setting of temporary authorisations for use by named patients.
- It is an alternative treatment for acute lymphoblastic leukaemia, mainly in paediatric care, in the event of the development of hypersensitivity (clinical allergy or silent inactivation) to native or pegylated L-asparaginase.
Clinical Benefit
Substantial |
- |
Clinical Added Value
minor |
- |
Therapeutic use
- |
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