DARZALEX

New indication.

Favourable opinion for reimbursement for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant, in combination with bortezomib, thalidomide and dexamethasone.

What therapeutic improvement?

Therapeutic improvement compared to the VTD protocol combining bortezomib, thalidomide and dexamethasone.

Role in the care pathway?

The current classification for myeloma, developed on the basis of International Myeloma Working Group criteria, divides patients into two categories: asymptomatic patients for whom simple monitoring is generally recommended, and symptomatic patients requiring appropriate management adapted to age and comorbidities.

In symptomatic patients, first-line treatment is dependent on whether the subject is eligible or not for intensive chemotherapy combined with autologous peripheral blood stem cell transplantation.

In patients eligible for intensive chemotherapy, the guidelines recommend induction treatment with four triple combination cycles, followed by an autologous stem cell transplant. The recommended treatments in this context are:

• the VTd protocol (bortezomib + thalidomide + dexamethasone),
• the VRd protocol (bortezomib + lenalidomide + dexamethasone), although this is off-label.

Post-ASCT consolidation treatment, with the same medicinal products used as induction treatment, may be proposed.

Role of the medicinal product in the care pathway

Given the demonstrated superiority of the D-VTd protocol combining DARZALEX (daratumumab) with bortezomib, thalidomide and dexamethasone in terms of progression-free survival compared to the VTd protocol, the D-VTd protocol is a first-line treatment for induction (16 weeks) and consolidation (8 weeks) in patients with previously untreated multiple myeloma who are eligible for autologous stem cell transplant.

Given the absence of comparative data between the two induction and consolidation protocols, the role of the D-VTd protocol compared to the VRd protocol (bortezomib, lenalidomide, dexamethasone), is not known.

The Committee wishes to draw the attention of prescribers to the need for specific vigilance with respect to the risk of immune deficiency induced by the long-term administration of DARZALEX (daratumumab). An excess of sometimes severe infectious episodes, particularly respiratory tract infection (including with opportunistic microorganisms), is observed in the study arm including DARZALEX (daratumumab), and is also reported in the literature and according to expert opinion.