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Daratumumab (Darzalex) Wins FDA Nod for Treatment of Multiple Myeloma

First human anti-CD38 monoclonal antibody for this indication

The FDA has approved daratumumab (Darzalex, Janssen Biotech) for the treatment of patients with multiple myeloma who have received at least three 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.

Daratumumab is the first human anti-CD38 monoclonal antibody (mAb) approved anywhere in the world. CD38 is a surface protein that is expressed by most, if not all, multiple myeloma cells. Daratumumab is believed to induce tumor cell death through multiple immune-mediated mechanisms of action, in addition to apoptosis, in which a series of molecular steps in a cell lead to its death. The product’s approval comes 2 months after its biologics license application was accepted for priority review by the FDA in September 2015. Daratumumab received a “breakthrough therapy” designation for this indication in May 2013.

In the pivotal open-label, phase II SIRIUS trial, treatment with single-agent daratumumab resulted in an overall response rate of 29.2% in patients who received a median of five prior lines of therapy, including a PI and an immunomodulatory agent. A stringent complete response was reported in 2.8% of patients; a very good partial response was reported in 9.4%; and a partial response was reported in 17%. 

For responders, the median duration of response was 7.4 months (range, 1.2 to 13.1+ months). At baseline, 97% of patients were refractory to their last line of therapy; 95% were refractory to both a PI and an immunomodulatory agent; and 77% were refractory to alkylating agents. Additional efficacy data from the phase I/II GEN501 monotherapy study –– published in the New England Journal of Medicine in August 2015 –– also supported the approval of daratumumab.

The warnings and precautions for daratumumab include infusion reactions, interference with serological testing, and interference with the determination of a complete response. The most frequently reported adverse events included fatigue, nausea, back pain, pyrexia, cough, and upper respiratory tract infection.

Source: Johnson & Johnson; November 16, 2015.

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