Genmab announced that its partner Janssen Biotech plans to start four new studies of daratumumab in multiple myeloma and amyloidosis. The studies described below are currently planned to start between the second half of 2017 and the first quarter of 2018 and may be subject to change. Darzalex is being developed under an August 2012 agreement in which Genmab granted Janssen Biotech, an exclusive worldwide license to develop, manufacture and commercialize the product.
Phase III study of daratumumab in smoldering multiple myeloma, phase III study comparing the subcutaneous and intravenous administration of daratumumab in relapsed and refractory multiple myeloma, phase III study of daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone for amyloidosis, phase II study of subcutaneous daratumumab in combination with standard of care regimens for frontline and relapsed multiple myeloma.
The plans for the new studies were announced at Johnson & Johnson's Pharmaceutical Business Review."Janssen's expansive development plans for daratumumab emphasize the commitment to test daratumumab broadly in many different clinical settings, which hopefully results in better treatment options for patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Darzalex (daratumumab) injection for intravenous infusion is indicated in the United States in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy and as a monotherapy for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent, or who are double-refractory to a PI and an immunomodulatory agent. DARZALEX is the first monoclonal antibody (mAb) to receive US Food and Drug Administration (FDA) approval to treat multiple myeloma.
Darzalex is indicated in Europe 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 for use as monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy.