The drug received breakthrough therapy designation for this pending indication in July 2016.
Janssen Biotech has submitted a supplemental Biologics License Application (sBLA) to the FDA for daratumumab (Darzalex), seeking a second indication for use 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.
Daratumumab received breakthrough therapy designation for this pending indication in July 2016. The sBLA seeking FDA approval for it is supported by data from 2 phase 3 studies.
Positive data from a phase 1 study that examined daratumumab in combination with pomalidomide and dexamethasone in patients who received at least 2 prior lines of therapy were also included in the sBLA.
Daratumumab was initially approved in November 2015 as a monotherapy for multiple myeloma patients who have received at least 3 prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent, or who are double-refractory to those drugs. It is the first CD38-directed monoclonal antibody approved in the world.