Janssen Biotech has submitted a supplemental biologics license application (sBLA) for daratumumab (Darzalex) to the FDA. The application seeks to expand the current indication, using daratumumab in combination with lenalidomide (an immunomodulatory agent) and dexamethasone, or with bortezomib (a proteasome inhibitor [PI]) and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy. Daratumumab, a human CD38-directed monoclonal antibody, won breakthrough therapy status for this pending indication in July 2016.
Janssen has also submitted a request for priority review of its sBLA. The FDA will inform Janssen whether a priority review has been granted within the next 60 days. If the FDA grants the request, the agency’s review of the sBLA should be completed within six months after its submission, or no later than February 2017.
Daratumumab is currently indicated 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.
The new regulatory submission for daratumumab was supported by data from two phase 3 studies:
- In the CASTOR trial, daratumumab in combination with bortezomib and dexamethasone reduced the risk of disease progression or death by 61% compared with bortezomib and dexamethasone alone in patients with multiple myeloma who received at least one prior therapy (hazard ratio [HR], 0.39; P < 0.0001).
- In the POLLUX trial, daratumumab in combination with lenalidomide and dexamethasone reduced the risk of disease progression or death by 63% compared with lenalidomide and dexamethasone alone in patients with multiple myeloma who received at least one prior therapy (HR, 0.37; P < 0.0001).
Globally, it has been estimated that 124,225 people were diagnosed with multiple myeloma and that 87,084 people died from the disease in 2015.
Source: Janssen Biotech(link is external); August 18, 2016.
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