Janssen begins rolling submission of daratumumab BLA to FDA for treatment of patients with multiple myeloma

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Janssen Research & Development, LLC (Janssen) has initiated the rolling submission of its Biologic License Application (BLA) for daratumumab to the U.S. 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 which 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.

Multiple myeloma is an incurable blood cancer. Approximately 26,850 new patients will be diagnosed with multiple myeloma and approximately 11,240 people will die from the disease in the U.S. in 2015. Patients who relapse after treatment with standard therapies, including PIs or IMiDs, have poor prognoses and few treatment options.

The regulatory submission for daratumumab will be primarily supported by data from the Phase 2 MMY2002 (SIRIUS) monotherapy study announced in May 2015 at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO), along with additional data from four other studies, including the Phase 1/2 GEN501 monotherapy study.

"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 has underscored the need for newer medicines with novel mechanisms of action," said Peter F. Lebowitz, M.D., Ph.D., Global Oncology Head, Janssen. "We are proud of the Breakthrough Therapy Designation daratumumab received and look forward to working in close collaboration with the FDA during its review."

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 U.S. by Janssen Biotech, Inc.

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