Janssen Biotech announce that the Food and Drug Administration (FDA) has approved Darzalex (daratumumab) injection for intravenous (IV) infusion for the treatment of patients with multiple myeloma 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 immunomodulatory agent. 

Darzalex is the first human anti-CD38 monoclonal antibody (mAB) to be approved and is believed to induce tumor cell death through multiple immune-mediated mechanisms, in addition to apoptosis, where a series of steps in a cell results in its death. 

RELATED: Daratumumab Monotherapy Promising for Multiple Myeloma

The FDA’s approval was based on data from the Phase 2 open-label MMY2002 (SIRIUS) study that showed treatment with Darzalex resulted in in an overall response rate (ORR) of 29.2% (95% CI: 20.8, 38.9) in patients who received a median of 5 prior lines of therapy, including a PI and an immunomodulatory agent. Stringent complete response (sCR) was seen in 2.8% o f patients, very good partial response in 9.4% of patients, and partial response in 17% of patients. Among responders, the median duration of response was 7.4 months (range 1.2–13.1+ months). 

Darzalex was approved under the accelerated approval process based on its response rate. Darzalex initially received Breakthrough Therapy Designation in May 2013 and its Biologics License Application (BLA) was accepted for Priority Review in September 2015. 

Darzalex injection is a preservative-free solution and will be available as 100mg/5mL and 400mg/20mL single-dose vials.  It is anticipated to launch within two weeks.

For more information call (800) 526-7736 or visit Darzalex.com.