The FINANCIAL — Janssen Biotech, Inc. (Janssen) announced on July 6 the opening of a daratumumab expanded access program (EAP) for eligible U.S. patients. Daratumumab is an investigational human anti-CD38 monoclonal antibody being evaluated in clinical trials as a treatment for people with multiple myeloma.
The multicenter, open-label EAP is available to multiple myeloma patients who are refractory to both a proteasome inhibitor (PI) and an immunomodulatory drug (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.
“We understand that heavily pre-treated or double refractory patients are in immediate need of new treatment options,” said Craig Tendler, M.D., Vice President, Late Development and Global Medical Affairs, Oncology, Janssen. “Through a research collaboration with the Multiple Myeloma Research Foundation, or MMRF, we have broadened our network of sites and sped site activation. Our goal is to provide timely access to daratumumab for multiple myeloma patients who may benefit while its application is under review with the U.S. Food and Drug Administration. MMRF’s significant experience in multiple myeloma research and innovation has helped to accelerate our efforts to meet this urgent patient need.”
In the U.S., EAPs are conducted as clinical trials and designed to make investigational medicines available for patients with serious or life-threatening illnesses who are ineligible for ongoing interventional trials and have exhausted currently available treatment options, according to Johnson & Johnson.
Up to 40 medical centers in the U.S. will enroll patients in the daratumumab EAP. The MMRF played a key role in identifying sites geographically distributed across the U.S. and opening sites for enrollment.
“While we work urgently each day to find solutions for all who are fighting multiple myeloma, our most critical focus is for those individuals whose multiple myeloma has relapsed and often have few or no active treatment options,” said Walter M. Capone, Chief Executive Officer and President of the MMRF. “In collaboration with pharmaceutical and biotech companies, the FDA, leading research institutions both within our wholly-owned subsidiary, the Multiple Myeloma Research Consortium and beyond, the MMRF is relentless in advancing the most promising science and accelerating the development of new, innovative multiple myeloma therapies. Our work together with Janssen on this important EAP is a perfect example of our mission in action, helping patients in every way possible, particularly at times of intense need.”
On May 1, 2013, daratumumab received Breakthrough Therapy Designation from the FDA for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a PI and an IMiD, the current standards of care, or who are double refractory to a PI and an IMiD. On June 5, 2015, Janssen announced it had initiated the rolling submission of its Biologics License Application (BLA) for daratumumab to the FDA for the treatment of this set of multiple myeloma patients. A rolling submission allows the company to submit portions of the regulatory application to the FDA as they are completed.[i] 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.
Discussion about this post