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PIXUVRI (pixantrone), anthracycline and related

HAEMATOLOGY - Update
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

Low

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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