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VIDAZA (azacitidine), antimetabolite
ONCOLOGY - New indication
Opinions on drugs -
Posted on
Oct 04 2017
Reason for request
Extension of indication
Insufficient clinical benefit in the treatment of acute myeloblastic leukaemia with more than 30% marrow blasts in adults ineligible for haematopoietic stem cell transplantation
- VIDAZA already has marketing authorisation in the treatment of acute myeloblastic leukaemia (AML) with more than 30% marrow blasts in adults ineligible for haematopoietic stem cell transplantation (HSCT).
- The pivotal study did not demonstrate any difference between VIDAZA and conventional treatments on overall survival (primary endpoint) or on quality of life. Its role has therefore not been established compared with the current therapeutic strategies.
Clinical Benefit
| Insufficient |
- |
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