Janssen Research & Development has announced that the FDA has accepted for Priority Review the Biologics License Application (BLA) for daratumumab as a treatment for patients with multiple myeloma who are 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.1 This designation shortens the review period to six months compared to 10 months for Standard Review. With today's announcement, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of March 9, 2016 to render a decision on the daratumumab application.
"Daratumumab has the potential to be the first anti-CD38 monoclonal antibody approved to treat multiple myeloma, offering these patients an important new treatment pathway," saidCraig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Oncology, Janssen. "The FDA's acceptance of our application for daratumumab marks an important step for people affected by multiple myeloma. We look forward to working with the FDA during this Priority Review."
The regulatory submission for daratumumab, which was initiated on June 5, 2015, is primarily supported by data from the Phase 2 MMY2002 (SIRIUS) monotherapy study, which were presented in May/June 2015 at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO). Additional data from four other studies, including the Phase 1/2 GEN501 monotherapy study, recently published in The New England Journal of Medicine, also support the submission. 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.
In August 2012, Janssen Biotech, Inc. 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 studies for daratumumab. If approved, daratumumab would be commercialized in the U.S. by Janssen Biotech, Inc.