Reason for request

Re-assessment of the actual benefit and the improvement in actual benefit

No clinical benefit demonstrated in the treatment of chronic lymphocytic leukaemia in monotherapy, indolent non-Hodgkin’s lymphoma and multiple myeloma

  

  • LEVACT has Marketing Authorisation in:
    •  first-line treatment of chronic lymphocytic leukaemia (Binet stage B or C) in patients for whom fludarabine combination chemotherapy is not appropriate. ;
    •  indolent non-Hodgkin’s lymphoma as monotherapy treatment in patients who have progressed during or within 6 months following treatment with rituximab or a rituximab-containing regimen. 
    •  first-line treatment of multiple myeloma (Durie-Salmon stage II with progress or stage III) in combination with prednisone for patients older than 65 years who are not eligible for autologous stem cell transplantation and who have neuropathy at the time of diagnosis precluding the use of thalidomide or bortezomib-containing treatment.
  • In CLL, LEVACT is currently used primarily in combination with other compounds such as rituximab. Its use in monotherapy (in its indication validated by the Marketing Authorisation) has become restricted in this situation.
  • In the treatment of patients with an indolent non-Hodgkin’s lymphoma progressing after treatment with rituximab, LEVACT is a second-line treatment.
  • In myeloma, in patients older than 65 years who are not eligible for autologous stem cell transplantation and treatment including thalidomide or bortezomib due to neuropathy, LEVACT is a first-line therapeutic option.

 

 


Clinical Benefit

Substantial

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Clinical Added Value

no clinical added value

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Not applicable

Therapeutic use

-

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