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

-

Contact Us

Évaluation des médicaments