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GLIVEC (imatinib), tyrosine kinase inhibitor
Reason for request
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.
Clinical Benefit
| Substantial |
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. |
Clinical Added Value
| major |
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) |
