Janssen Biotech announced the submission to the Food and Drug Administration (FDA) of a supplemental Biologics License Application (sBLA), with a request for Priority Review, for Darzalex (daratumumab), seeking to expand its current indication for the treatment of patients with multiple myeloma who have received at least one prior therapy.
Darzalex is currently indicated as monotherapy for the treatment of multiple myeloma in patients who have received ≥3 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. The application seeks to expand this indication to use daratumumab in combination with lenalidomide, an immunomodulatory agent, and dexamethasone, or bortezomib, a proteasome inhibitor, and dexamethasone.
The sBLA is based on data from two Phase 3 studies, CASTOR and POLLUX, evaluating daratumumab in patients with multiple myeloma who received at least one prior therapy. Results from the CASTOR study showed that daratumumab in combination with bortezomib and dexamethasone reduced the risk of disease progression or death by 61% vs. bortezomib and dexamethasone alone [HR=0.39; 95% CI (0.28-0.53), P<0.0001]. In the POLLUX study, daratumumab monotherapy and bortezomib plus dexamethasone, respectively, were shown to reduced the risk of disease progression or death by 63% vs. lenalidomide and dexamethasone alone [HR=0.37; 95% CI (0.27-0.52), P<0.0001]. Both studies showed that the safety profile of the daratumumab combination therapy was consistent with the known profile of each regimen studied. In addition to the Phase 3 data, Janssen also included findings from a Phase 1 study of daratumumab in combination with pomalidomide and dexamethasone in patients who received at ≥2 prior lines of therapy.
Darzalex is the first CD38-directed monoclonal antibody approved for the treatment of multiple myeloma.
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