Daratumumab (Darzalex) has been approved by the FDA 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.
Clinical studies have shown daratumumab, in combination with the immunotherapy agent lenalidomide and dexamethasone, reduced the risk of disease progression or death by 63 percent, compared to lenalidomide and dexamethasone alone, in patients with multiple myeloma who received a median of one prior therapy (Hazard Ratio [HR]=0.37; 95 percent CI [0.27, 0.52], p<0.0001).
In combination with bortezomib (a proteasome inhibitor [PI]) and dexamethasone, daratumumab reduced the risk of disease progression or death by 61 percent, compared to bortezomib and dexamethasone alone, in patients with multiple myeloma who received a median of two prior lines of therapy (HR=0.39; 95 percent CI [0.28, 0.53], p<0.0001).
The approval comes 3 months after a supplemental Biologics License Application was submitted to the FDA in August 2016. Daratumumab received Breakthrough Therapy Designation from the FDA for this indication in July 2016.
Daratumumab was first approved by the FDA in November 2015 as a monotherapy treatment for patients with multiple myeloma who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double refractory to a PI and immunomodulatory agent.
This most recent approval is supported by data from two phase III, open-label studies: POLLUX (MMY3003) and CASTOR (MMY3004). Overall, the safety of the daratumumab combination therapy was consistent with the known safety profiles of daratumumab monotherapy and lenalidomide plus dexamethasone, respectively.