BLINCYTO (blinatumomab), monoclonal antibody
Reason for request
High clinical benefit for relapsed or refractory Philadelphia chromosome-negative (Phi-) B-precursor acute lymphoblastic leukaemia and minor clinical added value compared to chemotherapy regimens
BLINCYTO has been granted a marketing authorisation for the treatment of adults presenting with relapsed or refractory Philadelphia chromosome-negative B-precursor acute lymphoblastic leukaemia (Phi- B ALL).
The median overall survival is increased with this medicinal product (+3.7 months) compared to standard chemotherapy regimens, without however retaining this benefit over time.
No benefit has been observed compared to standard chemotherapy regimens on the number of patients receiving haematopoietic stem cell (HSC) transplantation, the only curative treatment at this stage of the disease.
Its safety profile is marked by more frequent and more severe neurological adverse events and cytokine release syndromes than with standard chemotherapy regimens.
Its role in the therapeutic strategy with respect to HSC transplantation is not known, either as a "bridge" to transplantation or deferred transplantation, or as a substitute for transplantation.
Clinical Benefit
Substantial |
- |
Clinical Added Value
minor |
- |