Norwalk, Conn., July 6, 2015 – The Multiple Myeloma Research Foundation (MMRF) announced its collaboration with Janssen Biotech, Inc. on the daratumumab expanded access program (EAP), which launched today for eligible multiple myeloma patients in the United States. Daratumumab is an investigational human anti-CD38 monoclonal antibody currently being evaluated as a potential multiple myeloma monotherapy treatment.
“We employ every resource available to accelerate the development of novel treatments to improve and meaningfully extend the lives of multiple myeloma patients – especially those at greatest risk of disease progression and few or no treatment options,” said Walter M. Capone, Chief Executive Officer and President of the MMRF. “Together with our collaborators, we are working to quickly advance the development of the most promising therapies. Our collaboration with Janssen on this landmark EAP is just one example of how we are speeding access to novel therapies to patients who need them most.”
EAPs allow pharmaceutical companies to make investigational therapies available to patients with serious or life-threatening diseases that are not helped by currently available treatment options. The multicenter, open-label daratumumab EAP is available to multiple myeloma patients who are double refractory to both a proteasome inhibitor and an immunomodulatory drug or who have received three or more prior lines of therapy.
“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 (MMRF), we have broadened our network of sites and sped their 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.”
The MMRF has worked with Janssen in identifying sites across the U.S. and supporting its efforts for enrolling patients. Approximately half of the 40 medical centers involved in the EAP are MMRF partner institutions that comprise the Multiple Myeloma Research Consortium (MMRC). Previously in 2011, the MMRF partnered with Onyx Pharmaceuticals, Inc. on an EAP for carfilzomib (Kyprolis®).
The daratumumab EAP has specific inclusion and exclusion criteria for patients to be considered for enrollment in the program. Patients should contact their physician if they believe they are eligible or if they want to learn more. Additional information can be found at www.clinicaltrials.gov.
About Multiple Myeloma (MM)
Multiple myeloma (MM) is a cancer of the plasma cell. It is the second most common blood cancer. An estimated 26,850 adults (14,090 men and 12,760 women) in the United States will
be diagnosed with MM in 2015 and an estimated 11,240 people are predicted to die from the disease. The five-year survival rate for MM is approximately 45%, versus 28% in 1998.
About the Multiple Myeloma Research Foundation (MMRF)
The Multiple Myeloma Research Foundation (MMRF) was established in 1998 as a 501(c)(3) non-profit organization by twin sisters Karen Andrews and Kathy Giusti, soon after Kathy’s diagnosis with multiple myeloma. The mission of the MMRF is to relentlessly pursue innovative means that accelerate the development of next-generation multiple myeloma treatments to extend the lives of patients and lead to a cure. As the world’s number-one private funder of multiple myeloma research, the MMRF has raised $275 million since its inception and directs nearly 90% of total budget to research and related programming. As a result, the MMRF has been awarded Charity Navigator’s coveted four-star rating for 11 consecutive years, the highest designation for outstanding fiscal responsibility and exceptional efficiency.
About the Multiple Myeloma Research Consortium (MMRC)
The Multiple Myeloma Research Consortium (MMRC) is a 509(a)(3) non-profit organization that integrates leading academic institutions to accelerate drug development in multiple myeloma. The MMRC is the only consortium to join academic institutions through membership agreements, customized IT systems, and an integrated tissue bank.