On 26 July 2018, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced that it has recommended approval of daratumumab (Darzalex®) as a first-line treatment in combination with bortezomib, melphalan, and prednisone (VMP) for newly diagnosed (ND) MM patients who are ineligible for autologous stem cell transplant (ASCT)1.
Janssen’s monoclonal antibody daratumumab is currently approved by the EMA as a second-line treatment for relapsed/refractory multiple myeloma (RRMM) patients. Daratumumab is offered either as a monotherapy to patients with at least one prior treatment with a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD) or as a combination treatment with dexamethasone plus lenalidomide or bortezomib. Frontline approval was granted by the FDA in May 2018 - see previous MM Hub article.
CHMP’s recommendation is based on results from the ALCYONE study, a phase III, randomized, multi-center clinical trial with 706 participants. The results of this study, led by Dr Maria Victoria Mateos from the University Hospital Salamanca, Salamanca, Spain, were published in the New England Journal of Medicine in February 20182 and presented at ASH 2017 - see previous MM Hub article. NDMM patients who received daratumumab in combination with VMP showed superior 18-month progression-free survival (PFS) (71.6%; 95% confidence interval [CI], 65.5−76.8) compared to those receiving VMP alone (50.2%; 95% CI, 43.2−56.7) (hazard ratio for disease progression or death, 0.50; 95% CI, 0.38−0.65; P<0.001).
The European Commission will now examine whether to broaden daratumumab’s existing marketing authorization to front-line therapy in the European Union.