International Myeloma Foundation Celebrates ODAC Meeting Outcome on Minimal Residual Disease (MRD) Testing as an Early Endpoint for the Accelerated Approval of Myeloma Drugs in Clinical Trials: A Huge Win for the Global Myeloma Community

This conclusion is the result of almost 10 years of research carried out by the International Myeloma Foundation

STUDIO CITY, Calif., April 12, 2024 (GLOBE NEWSWIRE) — The International Myeloma Foundation (IMF) is exhilarated to share that through the leadership of the organization’s Chief Scientific Officer Dr. Brian G.M. Durie and the presentations from members of the collaborative research group, the i2TEAMM, the Oncologic Drug Advisory Committee (ODAC) unanimously voted in favor (12-0) of using minimal residual disease (MRD) as an early endpoint for accelerated approval in multiple myeloma clinical trials. This means that the FDA may approve multiple myeloma drugs in the development pipeline much sooner. To date, many myeloma drug approvals take 9-12 years and must demonstrate a progression-free survival of 5-8 years. With MRD testing as an early endpoint in clinical trials, researchers can reliably predict progression-free survival and overall survival for multiple myeloma patients, making it a precise early endpoint.

The IMF’s President and CEO, who is also a 28-year myeloma survivor, Yelak Biru said, “On the heels of the FDA approvals for two CAR T-cell therapies in the relapsed setting of myeloma, I am thrilled to learn that today’s ODAC meeting will only continue to support the expansion of available treatment options for multiple myeloma patients. It is the IMF’s vision to meet patients where they are in the stage of their disease and to realize a world where every myeloma patient can live life to the fullest, unburdened by this disease.”

At this morning’s ODAC meeting, IMF Chief Scientific Officer Brian G.M. Durie, MD (Cedars-Sinai Samuel Oschin Cancer Center) along with his colleagues Bruno Paiva, PhD (University of Navarra – Navarra, Spain); Dr. Qian Shi, PhD; (Mayo Clinic – Rochester, MN); and Kenneth C. Anderson, MD (Dana-Farber Cancer Institute and Harvard Medical School — Boston) gave testimonials at the ODAC meeting on approving minimal residual disease (MRD) testing as an early endpoint for the accelerated approval of multiple myeloma drugs in clinical trials.

ODAC is a specialized group that operates under the U.S. Food and Drug Administration (FDA). The committee’s primary role is to review and evaluate data concerning the safety and effectiveness of marketed and investigational human drug products for use in the treatment of cancer. Composed of 12 voting members, the ODAC plays a crucial role in the evaluation of new drugs, making recommendations concerning these drugs. The committee’s assessments and recommendations are then forwarded to the Commissioner of Food and Drugs. This process ensures that any new oncologic drugs brought to market have been thoroughly reviewed and evaluated for their safety and effectiveness.

Dr. Durie submitted an independent new drug application to ODAC on behalf of the IMF. He cited the IMF’s collaboration with the i2TEAMM (or, the International Independent Team for Endpoint Approval in Multiple Myeloma). This collaborative research group along with the IMF has spent nearly 10 years compiling the largest data sets to support the use of MRD as an endpoint for accelerated approval of myeloma drugs in the frontline settings of transplant-eligible, newly diagnosed multiple myeloma and non-transplant eligible, newly diagnosed multiple myeloma as well as for relapsed myeloma.

These efforts on the part of Dr. Durie and the i2TEAMM align with the IMF’s mission to improve the quality of life of myeloma patients while working toward prevention and a cure. The IMF is committed to increasing treatment options for patients to ensure they have the best care at the best time during their disease.  

ABOUT MULTIPLE MYELOMA       

Multiple myeloma is a cancer of the bone marrow plasma cells — white blood cells that make antibodies. A cancerous or malignant plasma cell is called a myeloma cell. Myeloma is called “multiple” because there are frequently multiple patches or areas in bone where it grows. It can appear as both a tumor and/or an area of bone loss, and it affects the places where bone marrow is active in an adult: the hollow area within the bones of the spine, skull, pelvis, rib cage, and the areas around the shoulders and hips.    

ABOUT THE INTERNATIONAL MYELOMA FOUNDATION      

Founded in 1990, the International Myeloma Foundation (IMF) is the first and largest global foundation focusing specifically on multiple myeloma. The Foundation’s reach extends to more than 525,000 members in 140 countries worldwide. The IMF is dedicated to improving the quality of life of myeloma patients while working toward prevention and a cure by focusing on four key areas: research, education, support, and advocacy. The IMF has conducted more than 250 educational seminars worldwide, maintains a world-renowned InfoLine, and in 2001, established the International Myeloma Working Group (IMWG), a collaborative research initiative focused on improving myeloma treatment options for patients. In 2012, the IMF launched the Black Swan Research Initiative®, a groundbreaking research project aimed at curing myeloma. The IMF can be reached at (800) 452-CURE (2873). The global website is www.myeloma.org.

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Media Contacts:

Peter Anton
Panton@myeloma.org

Jason London
Jlondon@myeloma.org