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PIXUVRI (pixantrone), anthracycline and related

Opinions on drugs - Posted on Jan 13 2017

Reason for request

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

Actual benefit low in monotherapy for aggressive non-Hodgkin B-cell lymphoma in 3rd or 4th line


  • Since 2012, PIXUVRI has had conditional Marketing Authorisation as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL).
  • The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.
  • No new study is available since the previous assessment. Its therapeutic benefit therefore remains to be confirmed considering:

       - the non-optimal level of demonstration of efficacy in a single study,

       - the marked safety profile, especially for a haematological (neutropenia) and cardiac toxicity, 

       - the absence of data on quality of life, in particular at this advanced stage of the disease.

  •  The role of this cytotoxic agent related to anthracyclines in monotherapy is restricted to the 3rd or 4th line of the therapeutic strategy.


Clinical Benefit



Clinical Added Value

no clinical added value


Therapeutic use


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