Janssen Biotech files supplemental Biologics License Application (sBLA) at FDA for daratumumab (Darzalex)for use with lenalidomide and dexamethasone or bortezomib and dexamethasone for multiple myeloma.

Janssen Biotech, Inc.has announced a supplemental Biologics License Application (sBLA) for daratumumab (Darzalex) has been submitted to the FDA. The application seeks to expand the current indication, using daratumumab in combination with lenalidomide (an immunomodulatory agent) and dexamethasone, or bortezomib (a proteasome inhibitor [PI]) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Janssen has also submitted a request for Priority Review of this sBLA. The FDA will inform Janssen whether a Priority Review has been granted within the next 60 days. If the FDA grants Priority Review, the review should be completed within six months .

The regulatory submission for daratumumab is supported by data from two Phase III studies: 1.the CASTOR (MMY3004) clinical study which showed daratumumab in combination with bortezomib and dexamethasone reduced the risk of disease progression or death by 61 percent, compared to bortezomib and dexamethasone alone, in patients with multiple myeloma who received at least one prior therapy (Hazard Ratio [HR] = 0.39; 95 percent CI [0.28-0.53], p<0.0001). overall, the safety of the daratumumab combination therapy was consistent with the known safety profile of daratumumab monotherapy and bortezomib plus dexamethasone, respectively. these results were presented at the 52nd annual meeting of the american society of clinical oncology (asco) in june 2016.>

2. The POLLUX (MMY3003) clinical study which showed daratumumab in combination with 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 at least one prior therapy (HR=0.37; 95 percent CI [0.27-0.52], p<0.0001). overall, the safety of the daratumumab combination therapy was consistent with the known safety profile of daratumumab monotherapy and lenalidomide plus dexamethasone, respectively. these results were presented at the 21st annual congress of the european hematology association (eha) in june 2016.>

Comment:In November 2015, Darzalex was approved as a monotherapy by the FDA for the treatment of 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 an immunomodulatory agent. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. In May 2016, the European Commission (EC) granted conditional approval to Darzalex monotherapy for the treatment 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.