With the submission, the company looks to treat multiple myeloma patients 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.
A rolling submission will enable the company to submit portions of the regulatory application to the FDA as they are completed.
Daratumumab is an investigational human anti-CD38 monoclonal antibody, and secured breakthrough therapy designation by the FDA for this set of patients in May 2013. The designation aims to expedite the development and review time for a potential new medicine.
Janssen Global Oncology head Peter Lebowitz said: "Despite therapeutic advances over the last 10 years, multiple myeloma remains an incurable disease, and many people eventually relapse or grow resistant to available therapies, which have underscored the need for newer medicines with novel mechanisms of action."
Daratumumab’s regulatory submission will be primarily supported by data from the Phase 2 MMY2002 (SIRIUS) monotherapy study announced in May 2015, along with additional data from four other studies, including the Phase 1/2 GEN501 monotherapy study.
Janssen is the global sponsor of all current and future clinical studies for daratumumab, except the one that was sponsored globally by the French multiple myeloma cooperative group, Intergroupe Francophone du Myelome (IFM)
If approved by the FDA, Janssen Biotech would commercialize daratumumab in the US.
Claimed to be an incurable blood cancer, multiple myeloma starts in the bone marrow and is characterized by an excess proliferation of plasma cells.
Multiple myeloma is believed to be the third most common blood cancer in the US, following only leukemia and lymphoma.