The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended broadening the existing marketing authorisation for Janssen’s Darzalex (daratumumab) as a frontline treatment.
Approval
Currently, in Europe, daratumumab is 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. It is also indicated for use as a monotherapy in 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.
This latest positive opinion means that daratumumab in combination with bortezomib, melphalan and prednisone, is recommended for initial use by the CHMP in the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT). The recommendation has been based on the results of the randomised, open-label, multicentre Phase III ALCYONE (MMY3007) study that were recently published in the New England Journal of Medicine.
“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, PhD, 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.”
“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,” added Dr Catherine Taylor, Europe, Middle East and Africa (EMEA) Haematology 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.”
A final decision regarding the approval of daratumumab for newly diagnosed patients is expected from the European Commission in the coming months. It has already been approved for use in the frontline setting in the US.