Janssen Research & Development, LLC (Janssen) has initiated the rolling submission of its biologic license application (BLA) for daratumumab to the US Food and Drug Administration (FDA) 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 (IMiD), or who are double refractory to a PI and an IMiD. Daratumumab, an investigational human anti-CD38 monoclonal antibody, received Breakthrough Therapy Designation by the FDA for this set of patients in May 2013. A rolling submission allows the company to submit portions of the regulatory application to the FDA as they are completed.

In August 2012, Janssen Biotech, Inc. and Genmab A/S entered into an agreement that granted Janssen a worldwide exclusive license to develop, manufacture and commercialize daratumumab. With the exception of one study sponsored globally by the French multiple myeloma cooperative group, Intergroupe Francophone du Myelome (IFM), Janssen is the global sponsor of all current and future clinical studies for daratumumab.

Daratumumab is the second medicine in the Janssen oncology portfolio to receive Breakthrough Therapy Designation, which is intended to expedite the development and review time for a potential new medicine. If approved, daratumumab would be commercialized in the US by Janssen Biotech, Inc.

Source: Johnson & Johnson