Posted by Michael Wonder on 24 Aug 2016
Janssen submits application to the EMA to expand use of Darzalex (daratumumab) to include combination with standard of care regimens
24 August 2016 - Phase 3 data supporting submission suggests potential clinical benefit of daratumumab as a backbone therapy in combination with either a proteasome inhibitor or an immunomodulatory agent for relapsed multiple myeloma patients.
Janssen-Cilag today announced the submission of a type II variation application to the EMA, seeking to broaden the existing marketing authorisation for the immunotherapy Darzalex (daratumumab) 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 and dexamethasone.
Daratumumab is currently approved by the European Commission 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.
