Janssen Research & Development is seeking approval from the US Food and Drug Administration (FDA) for its daratumumab to treat patients with multiple myeloma.
The company has started the rolling submission of its biologic licence application (BLA) for daratumumab to treat 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 is an investigational human anti-CD38 monoclonal antibody that obtained FDA breakthrough therapy designation for this set of patients in May 2013.
Janssen global oncology head Dr Peter F Lebowitz said: "Despite therapeutic advances over the last ten years, multiple myeloma remains an incurable disease, and many people eventually relapse or grow resistant to available therapies, which has underscored the need for newer medicines with novel mechanisms of action.
"We are proud of the breakthrough therapy designation daratumumab received and look forward to working in close collaboration with the FDA during its review."
The regulatory submission for daratumumab was based on data from the Phase II MMY2002 (SIRIUS) monotherapy study, as well as additional data from four other studies, including the Phase I/II GEN501 monotherapy study.
In August 2012, Janssen Biotech and Genmab have partnered, under which Janssen received a worldwide exclusive licence to develop, commercialise, and manufacture daratumumab.
Janssen is the global sponsor of all current and future clinical trials for daratumumab, with the exception of one study sponsored globally by the French multiple myeloma cooperative group, Intergroupe Francophone du Myelome (IFM).
Image: Bone marrow aspirate showing the histologic correlate of multiple myeloma under the microscope. Photo: courtesy of KGH.