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BESPONSA (inotuzumab ozogamicin), antineoplastic monoclonal antibody

HAEMATOLOGY - New indication
Opinions on drugs - Posted on Jun 27 2018

Reason for request


  • For the treatment of relapsed or refractory CD22 positive B-cell precursor acute lymphoblastic leukaemia, Philadelphia chromosome-negative (Phi-): low clinical benefit and no proven clinical added value compared to standard chemotherapies

  • Philadelphia chromosome-positive (Phi+): clinical benefit considered insufficient to justify  public funding


  • BESPONSA has been granted a marketing authorisation for the treatment of adults with relapsed or refractory CD22 positive B-cell precursor acute lymphoblastic leukaemia (ALL), Adult patient with Philadelphia chromosome-positive (Phi+) should have failed treatment with at least 1 tyrosine kinase inhibitor (TKI).

  • In relapsed or refractory B cell ALL, no gain in overall survival has been demonstrated compared to standard chemotherapies. The haematological remission rate (80.7% versus 29.4%) and use of haematopoietic stem cell transplant (43% versus 11%) were higher in the inotuzumab ozogamicin group than in the standard chemotherapy group, with however a higher 100-day mortality post-transplant with BESPONSA than with standard chemotherapies (26% versus 6%).

  • There is a higher risk of hepatic veno-occlusive disease/sinusoidal obstruction syndrome with BESPONSA than with standard chemotherapies; this adverse event may be serious or even fatal.

  • In relapsed or refractory Phi+ ALL, BESPONSA has no place in the therapeutic strategy.



Clinical Benefit




Clinical Added Value

no clinical added value


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