BLINCYTO (blinatumomab), monoclonal antibody

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.