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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

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Clinical Added Value

minor

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