FARYDAK (panobinostat), antineoplastic agent

ONCOLOGY - New medicinal product
Opinions on drugs - Posted on Aug 23 2016

Reason for request

Inclusion

No clinical added value in the treatment of patients with relapsed and/or refractory multiple myeloma who have already received at least 2 lines of treatment including bortezomib and an immunomodulatory agent

  • FARYDAK has Marketing Authorisation in the treatment of relapsed and/or refractory multiple myeloma, in combination with bortezomib and dexamethasone in patients who have already received at least two prior lines of treatment including bortezomib and an immunomodulatory agent.
  • Its efficacy on the overall response rate, evaluated from noncomparative data, was modest after 8 cycles of treatment. It is intended as a backup therapy. The toxicity of the combination of panobinostat with bortezomib and with dexamethasone, especially gastrointestinal and haematological, is significant.

Clinical Benefit

Moderate

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Clinical Added Value

no clinical added value

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Therapeutic use

-

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