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GLIVEC (imatinib), tyrosine kinase inhibitor

ONCOLOGY - New indication
Opinions on drugs - Posted on Jun 02 2015

Reason for request

Extension of indication

   

Major improvement in the treatment of children with Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL)

 

 

 

  • GLIVEC now has Marketing Authorisation in the treatment of children with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL), integrated with chemotherapy.

  • Integrated with chemotherapy, it represents a major therapeutic advance in terms of event-free survival and overall survival at 4 years in this indication.

 

 


Actual benefit

Important

The Committee finds that the actual benefit of GLIVEC is substantial in the treatment of children with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy.


Improvement in actual benefit

I (majeur)

In the therapeutic strategy for paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia (Ph+ ALL) integrated with chemotherapy, GLIVEC provides a major improvement in actual benefit. (IAB I)