C. Ola Landgren, Leader, Translational and Clinical Oncology Program/Experimental Therapeutics at Sylvester Comprehensive Cancer Center, shared on LinkedIn:
“Nearly 20 years ago, our myeloma team at the National Cancer Institute (NCI)/The National Institutes of Health (NIH) began pursuing a question: Could measuring very small amounts of residual myeloma help bring effective new treatments to patients sooner?
Today, that work is helping change how myeloma drugs are developed.
Our collaborative EVIDENCE meta-analysis, published in Blood Journal in 2024 (see reference), helped establish the scientific foundation for using minimal residual disease (MRD) as an early endpoint to support accelerated approval.
Together with other independent research efforts, it contributed to a unanimous FDA advisory committee vote (12-0) supporting this approach.
This year brought two major milestones: FDA draft guidance addressing MRD in myeloma drug development (see reference), followed in August by accelerated approval of an iberdomide-based combination using MRD-negative complete response as the key efficacy endpoint (see reference).
The significance for patients is clear: promising therapies can become available earlier, while studies continue to confirm their long-term clinical benefit.
This progress reflects years of collaboration among patients, researchers, clinical teams, industry partners and regulators. It shows what sustained scientific teamwork can achieve.
At the Sylvester Myeloma Institute at the University of Miami’s Sylvester Comprehensive Cancer Center, our team is building on this foundation.
We are developing new therapies and testing how deep, sustained responses can guide more individualized treatment, including when treatment can safely be reduced or stopped.
Our goal is longer life, better quality of life and, wherever possible, more time free from treatment. Our ultimate goal is to develop a cure for myeloma.
That is the future we are working to build.”
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