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REVLIMID (lénalidomide)

Multiple myeloma - Sector: Hospital
Opinions on drugs - Posted on Mar 31 2020

Reason for request

New indication

Key points

Favourable opinion for reimbursement as monotherapy in the maintenance treatment of adult patients with previously untreated multiple myeloma who have undergone autologous stem cell transplantation.

What therapeutic improvement?

No clinical added value compared to no therapy.

Role in the care pathway?

In symptomatic patients with previously untreated multiple myeloma, the first-line treatment depends on eligibility for intensive chemotherapy combined with autologous stem cell transplantation.

In eligible patients, having received intensive chemotherapy combined with autologous stem cell transplantation, post-transplant consolidation treatment may be considered with the aim of improving the quality and extent of the response. Post-transplant maintenance therapy aimed at delaying the first relapse is one of the treatment options that may be proposed in the first-line treatment strategy for multiple myeloma.

Role of the REVLIMID (lenalidomide) in the care pathway?

REVLIMID (lenalidomide) is a maintenance treatment following autologous stem cell transplantation.

As a precaution, the Committee recommends that REVLIMID (lenalidomide) be administered for a maximum period of two years and not until disease progression, in the absence of data supporting the optimal duration of this treatment.

 

 


Clinical Benefit
Low

The clinical benefit of REVLIMID (lenalidomide) is low in the indication “as monotherapy in the maintenance treatment of adult patients with previously untreated multiple myeloma who have undergone autologous stem cell transplantation.

Clinical Added Value
no clinical added value

Considering:

  • demonstration of the superiority of REVLIMID (lenalidomide) compared to placebo in two clinical trials in terms of progression-free survival time (absolute increase of 15 months or 18 months depending on the study considered) without robust demonstration of an increase in overall survival time,
  • the potentially serious haematological and infectious adverse events that may occur during maintenance treatment with REVLIMID (lenalidomide),
  • the additional risk of the development of secondary cancers,
  • the absence of data demonstrating maintenance of the quality of life of patients treated with REVLIMID (lenalidomide) in comparison with no therapy, in view of the potentially serious events and the regular laboratory monitoring required during treatment with REVLIMID (lenalidomide), whereas no therapy gives patients a period without active treatment during their disease,

the Committee considers that REVLIMID (lenalidomide), as a maintenance treatment following autologous transplantation, provides no clinical added value (CAV V) compared to no therapy, in adult patients with previously untreated multiple myeloma who have undergone autologous stem cell transplantation.

 

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