DARZALEX (daratumumab) - Myélome multiple

Key points

Maintain favorable opinion on the reimbursement of DARZALEX (daratumumab) in combination with lenalidomide and dexamethasone, or bortezomib anddexamethasone, for the treatment of adult patientswith multiple myeloma who have received at least one prior therapy.

Therapeutic improvement?

Therapeutic improvement compared to the Vd [VELCADE (bortezomib), dexamethasone] and Rd [REVLIMID (lenalidomide), dexamethasone] combination.

Role in therapeutic strategy?

The current treatment of refractory or relapsed MM generally involves combinations of medicinal products of different and complementary mechanisms of action, as bi- or tritherapy including immunomodulatory agents (IMiDs) and/or proteasome inhibitors (PIs) and/or monoclonal antibodies, associated with dexamethasone. 

The choice of relapse treatments accounts for the prior first-line treatment and the remaining options available, as well as age, duration of the first remission, and circumstances of the relapse, peripheral stem cell  (PSC) availability, general health state, and comorbidities.

Role of DARZALEX (daratumumab) in the therapeutic strategy:

DARZALEX as tritherapy, in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, is a treatment option for multiple myeloma in adult patients having received at least one previous line treatment.

The choice between the different therapeutic options available for the treatment of multiple myeloma from the second-line treatment must take account particularly of the refractory or non-refractory status to lenalidomide and previous exposure to daratumumab as a first-line treatment, the patient’s characteristics (age, comorbidities), as well as the level of evidence and the toxicity profile.

The Committee points out that the role of DARZALEX (daratumumab), now recommended in the first line of treatment, regardless of autologous peripheral blood stem cell transplantation eligibility status, is decreasing in the relapse setting and its benefit is considerably reduced in subsequent treatments. However, there are still patients who have not received DARZALEX (daratumumab) and are likely to receive it in a subsequent line.

The Committee would also like to point out the lack of direct comparison to KYPROLIS (carfilzomib) in association with Rd, meaning that it is not possible to place DARZALEX (daratumumab) versus to this alternative strategy in a context where there is also evidence of an improvement of overall survival with this regimen.