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BESPONSA (inotuzumab ozogamicine)

Opinions on drugs - Posted on Oct 10 2022

Reason for request

Reassessment

Key points

Approval of reimbursement only for the treatment of adult patients with relapsed or refractory Philadelphia chromosome-negative (Phi-), CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL).

Actual clinical benefit is now deemed to be substantial (previously it was low) in this indication.

Therapeutic improvement?

No improvement in relation to chemotherapy.

Role in therapeutic strategy?

In adult patients with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL) with Philadelphia chromosome negative (Phi-), the treatment options (in addition to BESPONSA (inotuzumab ozogamicin)) are:

  • further induction polychemotherapy (may or may not be similar to first line, conventional or clofarabine-based) followed by consolidation with allogeneic HSCT if a second complete remission is achieved, and if eligible,
  • BLINCYTO (blinatumomab) in adult patients with CD 19 positive relapsed or refractory Philadelphia chromosome negative B-cell precursor ALL,
  • KYMRIAH (tisagenlecleucel) in children and young adults (up to and including 25 years of age) with B-cell ALL that is refractory, in relapsed post-transplant or in second or later relapse,
  • palliative supportive care.

 Role of the medicinal product

BESPONSA (inotuzumab ozogamicin) is a treatment option for adult patients with acute relapsed or refractory Philadelphia chromosome-negative (Phi-), CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL).

Given the lack of direct comparative data (concurrent development) or indirect comparative data of an acceptable methodological quality, its role vis-à-vis BLINCYTO (blinatumomab) and KYMRIAH (tisagenlecleucel) cannot be specified.


Clinical Benefit
Substantial

The Committee deems that the actual clinical benefit of BESPONSA (inotuzumab ozogamicin) is substantial in relapsed or refractory Philadelphia chromosome negative (Phi-), CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL).

Clinical Added Value
no clinical added value

Considering:

  • the evidence of the superiority of BESPONSA (inotuzumab ozogamicin) in relation to chemotherapy concerning the complete remission (CR) rate, or complete remission with incomplete haematologic recovery (CRi), with a point-estimated absolute difference of 51% (CI 97.5% [38-64]), considered as clinically relevant, in a randomised, open-label, phase III study;
  • the lack of evidence of an increase in overall survival;
  • the lack of formal conclusions that can be drawn from the quality-of-life results;
  • the more frequent occurrence of occlusive venoocclusive disease/sinusoidal obstruction syndrome;
  • higher 100-day post-transplant mortality than with chemotherapy;

the Committee deems that BESPONSA (inotuzumab ozogamicin) provides no clinical added value (CAV V) compared to standard chemotherapy in adult patients with relapsed or refractory CD22-positive B-cell precursor acute lymphoblastic leukaemia (ALL) (with Philadelphia chromosome negative (Phi-)).

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