The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended broadening the existing marketing authorization for Darzalex® (daratumumab) for use as frontline (initial) therapy. The recommendation is for the use of daratumumab in combination with bortezomib, melphalan and prednisone, for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
"Multiple myeloma becomes harder to treat each time it returns, so the goal of initial therapy is to prevent the cancer from progressing for as long as possible," said Dr Maria-Victoria Mateos, Ph.D., lead ALCYONE study investigator and Director of the Myeloma Unit at University Hospital of Salamanca-IBSAL Salamanca, Spain. "Selecting the right treatment regimen for newly diagnosed patients is critical to their long-term survival, especially those who are transplant ineligible, so daratumumab could offer an important new standard of care in this indication."
The CHMP's recommendation is based on results from the randomized, open-label, multicenter Phase 3 ALCYONE (MMY3007) study, recently published in the New England Journal of Medicine. Additional information about this study can be found at www.ClinicalTrials.gov (NCT02195479).
"Clinical findings have consistently demonstrated the compelling benefit daratumumab offers across all lines of therapy in multiple myeloma, and this positive recommendation brings us one step closer to providing this ground-breaking option to more patients in Europe," said Dr Catherine Taylor, Europe, Middle East and Africa (EMEA) Hematology Therapeutic Area Lead, Janssen. "Through our research and development efforts, we remain committed to identifying and treating patients earlier and earlier in their cancer journey, when they are healthier and have the best chance at lasting remission."
In Europe, daratumumab is currently indicated for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy; and as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent, and who have demonstrated disease progression on the last therapy.
A final decision regarding the approval of daratumumab for newly diagnosed patients is expected from the European Commission in the coming months.
In the U.S.A., daratumumab in the frontline setting was granted Priority Review by the U.S. Food and Drug Administration (FDA) in January this year, and was recently approved for use in this indication.