PIXUVRI (pixantrone), anthracycline and related
Reason for request
- 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 Added Value
|no clinical added value||