Daratumumab Seeks Second Indication for Multiple Myeloma

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.

  • The CASTOR (MMY3004) trial, which demonstrated that daratumumab in combination with bortezomib and dexamethasone could reduce the risk of disease progression or death by 61%, compared with bortezomib and dexamethasone alone, in multiple myeloma patients with who received at least one prior therapy. The drug’s safety profile was also consistent with the known safety profiles of daratumumab monotherapy and bortezomib plus dexamethasone.
  • The POLLUX (MMY3003) trial, which found that daratumumab in combination with lenalidomide and dexamethasone could reduce the odds of disease progression or death by 63%, compared with lenalidomide and dexamethasone alone, in multiple myeloma patients with who received at least one prior therapy.

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.