The US Food and Drug Administration (FDA) has accepted for priority review the biologics license application (BLA) for Janssen’s daratumumab for treating patients with multiple myeloma that is refractory to both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who have received three or more prior lines of therapy, including a PI and an IMiD. This is referred to as “double refractory” multiple myeloma, which occurs when a patient’s disease has become resistant to at least two of the most commonly utilized and active classes of anti-myeloma agents. Daratumumab, an investigational human anti-CD38 monoclonal antibody, received breakthrough therapy designation from the FDA for this patient population in May 2013.

The FDA grants priority review to investigational therapies that if approved, may offer significant improvements in the treatment, prevention, or diagnosis of a serious condition. This designation shortens the review period to six months compared to 10 months for standard review. The FDA’s target date to render a decision on the daratumumab application is March 9, 2016.

In August 2012, Janssen Biotech, Inc., part of Johnson & Johnson, and Genmab A/S entered a worldwide agreement that granted Janssen an exclusive license to develop, manufacture, and commercialize daratumumab. Janssen is the global sponsor of all but one clinical study for daratumumab. If approved, daratumumab would be commercialized in the US by Janssen Biotech, Inc.

Source: Johnson & Johnson