Janssen has submitted an application to the European Medicines Agency (EMA) to expand the use of DARZALEX®▼ (daratumumab) to include a combination with standard of care regimens.
The submission of a Type II variation application to the EMA seeks to broaden the existing marketing authorisation for the immunotherapy to include treatment of adult patients with relapsed multiple myeloma who have received at least one prior therapy. The expanded indication is based on daratumumab in combination with lenalidomide (an immmunomodulatory agent) and dexamethasone, or bortezomib (a PI) and dexamethasone.
Daratumumab is currently approved by the European Commission (EC) for monotherapy 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.
Jane Griffiths, Company Group Chairman, Janssen Europe, Middle East and Africa, said that although multiple myeloma remains an incurable illness, this application represents “an important step forward in further realising the potential of daratumumab”.
The regulatory submission is now pending validation by the EMA and is primarily supported by data from two Phase 3 studies, the CASTOR and POLLUX clinical trials, in patients with multiple myeloma who have received one or more prior lines of therapy, showing combination of daratumumab with a PI or immunomodulatory agent resulted in a >60% reduction in the risk of disease progression or death.
The submission also included data from the Phase 1 study of daratumumab in combination with pomalidomide and dexamethasone in patients who received at least two prior lines of therapy.
The Type II variation application follows the recent submission to the U.S. Food and Drug Administration of a supplemental Biologics License Application for daratumumab in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone for treatment of patients with multiple myeloma who have received at least one prior therapy.