The International Myeloma Foundation Proudly Announces EMA-CHMP Positive Qualification Advice to i2TEAMM Novel Biomarker Procedure Application on the Use of MRDnegCR as an Intermediate Early Endpoint for Conditional Market Approval in Myeloma Clinical…

Another Remarkable Milestone for the IMF and i2TEAMM, Following the FDA-ODAC Unanimous 12-0 Vote in April 2024

STUDIO CITY, Calif., July 02, 2025 (GLOBE NEWSWIRE) -- The International Myeloma Foundation (IMF) and the collaborative stakeholder group i2TEAMM (International Independent Team for Endpoint Approval of Myeloma MRD), which includes top global myeloma experts, proudly announce the positive outcome of the i2TEAMM’s application on the use of minimal residual disease (MRD) as an early endpoint in myeloma clinical trials.

Building on the tremendous success and momentum gained from the 12-0 unanimous vote given by the U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) in April 2024, the i2TEAMM submitted an application (Doc Ref: EMADOC-360526170-2374344) to the EMA-CHMP on November 15, 2024, regarding the use of MRD “as an early endpoint in clinical trials conducted in patients with multiple myeloma in order to support regulatory decisions.” The CHMP, as the European Medicines Agency's (EMA's) committee, plays a central role in the scientific evaluation of marketing authorization applications for medicines for human use.

In a scientific advice letter, the CHMP stated: “On 5/22/2025, the CHMP met and adopted the advice to be given to the applicant. CHMP agrees that, depending on the setting, a role for MRDnegCR as an endpoint to support (conditional) approval of a compound while the obligation to demonstrate long-term benefit remains, can be envisaged. This implies that the trials should be adequately planned to demonstrate a benefit in PFS or OS.”

IMF Chairperson of the Board S. Vincent Rajkumar, MD, said: "I am very pleased with the CHMP opinion that MRD can be considered as a potential early endpoint for conditional approval of treatments in myeloma. This is great news for the field and is in line with a similar recommendation by ODAC in the United States. We are an international organization, and we are committed to accelerating the availability of effective new treatments to myeloma patients worldwide. I applaud the efforts of the i2TEAMM investigators and our entire team at the International Myeloma Foundation."

"The acceptance of the IMF/ i2TEAMM application by the EMA-CHMP represents one of the most significant milestones in our collective mission to accelerate innovation and cure in multiple myeloma. Recognizing MRD as a valid early endpoint brings us one step closer to delivering more timely, effective therapies to patients. This scientific advancement reflects the strength of global collaboration and data-driven progress in the field," said Nikhil Munshi, MD (Dana-Farber Cancer Institute — Boston, MA), a member of the i2TEAMM Executive Committee, the IMF Scientific Advisory Board, and the IMF Board of Directors.

Jesús San Miguel, MD, PhD (University of Navarra — Pamplona, Spain), who is also a member of the i2TEAMM Executive Committee and the IMF Scientific Advisory Board, praised the EMA-CHMP's decision and said: “This was the result of a long-standing effort of the International Myeloma Foundation, Academic Centers, and Industry that worked together under the umbrella of the i2TEAMM project. The new MRD endpoint will represent a sensitive early readout for conditional drug approval, allowing patients timely access to newer treatment options although trials should be adequately planned to demonstrate a benefit in PFS or OS."

“The International Myeloma Foundation is elated at the groundbreaking outcomes of the i2TEAMM’s efforts, both in the FDA-ODAC and the EMA-CHMP. As these remarkable milestones bring us closer to a cure, we look forward to a future where the IMF’s vision can finally be achieved: A world where every myeloma patient can live life to the fullest, unburdened by the disease,” said IMF Interim CEO and Senior VP of Strategic Planning Diane Moran, RN, MA, EdM.

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  

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