Reason for request

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

No clinical benefit demonstrated, in monotherapy or in combination with dexamethasone, in relapsed multiple myeloma in patients who have already undergone or who are ineligible for a haematopoietic stem cell transplant

Insufficient clinical benefit in combination with pegylated liposomal doxorubicin (CAELYX)

 

  • This focus concerns only the Marketing Authorisation indications of VELCADE in the treatment of relapsed myeloma, i.e. in patients who have already undergone or who are ineligible for a haematopoietic stem cell transplant.

It is indicated in second-line as monotherapy or in combination with dexamethasone or CAELYX.

It is also indicated in third-line as monotherapy.

  • The available data and lack of comparative data versus the recommended alternatives (including REVLIMID in combination with dexamethasone) do not demonstrate a clinical benefit in the current therapeutic strategy for relapsed multiple myeloma.
  • Its place in monotherapy or in combination with dexamethasone is restricted, particularly in monotherapy for patients who have received at least two prior treatments.
  • According to experts, its combination with CAELYX has no place in the therapeutic strategy of relapsed multiple myeloma having received at least one line of treatment.

 


Clinical Benefit

Substantial

-

Insufficient

Clinical Added Value

no clinical added value

-


Therapeutic use

-

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