Favourable opinion for reimbursement for “BLINCYTO is indicated as monotherapy for the treatment of adults with Philadelphia chromosome-negative CD19-positive B-cell precursor acute lymphoblastic leukaemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.”
Clinical Benefit
Substantial
The Committee deems that the clinical benefit of BLINCYTO (blinatumomab) is substantial in the MA indication.
Clinical Added Value
no clinical added value
Considering:
the absence of robust comparative data, an interference with the specific effect of allogeneic HSCT and the lack of robust evidence of the clinical relevance of the primary endpoint (MRD complete response), which do not enable any robust conclusion to be reached with respect to the therapeutic contribution of BLINCYTO (blinatumomab) compared to the available alternatives in adults with Philadelphia chromosome-negative CD19-positive B-cell precursor ALL in first or second complete remission with positive minimal residual disease (MRD);
a safety profile marked, in particular, by the frequent occurrence of neurological disorders, infections and cytokine release syndrome (3.4% of patients);
a partially met medical need with a benefit of having an additional alternative for patients receiving post-induction consolidation therapy;
and pending the results of the phase 3 study (E1910) comparing blinatumomab in combination with chemotherapy versus consolidation chemotherapy in adult patients (≥ 30 and ≤ 70 years) with Phi- CD19+ B-cell ALL with negative MRD;
the Committee considers that, as the dossier currently stands, BLINCYTO (blinatumomab) 38.5 µg powder for concentrate and solution for solution for infusion, as monotherapy, provides no clinical added value (CAV V) in the care pathway for adults with Philadelphia chromosome-negative CD19-positive B-cell precursor acute lymphoblastic leukaemia (ALL) in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1%.
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