BESPONSA (inotuzumab ozogamicin), antineoplastic monoclonal antibody
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 Added Value
|no clinical added value||