Introduction In April 2024, the U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) unanimously (12–0) voted to accept minimal residual disease (MRD) negativity as a primary endpoint in multiple myeloma (MM) clinical trials seeking accelerated approval. This marks a regulatory shift, aiming to speed up the availability of new treatments. The decision stems [...]
Introduction Minimal residual disease (MRD) is a critical prognostic indicator in multiple myeloma, typically assessed using invasive bone marrow-based assays. However, these methods have shown limited success when applied to blood. Next-generation flow (NGF) is mainly useful in patients with high levels of circulating disease, which is a phenomenon that has been [...]
Introduction As detection technology and therapeutics have improved, minimal residual disease (MRD) has become a pivotal prognostic marker in multiple myeloma (MM), particularly for predicting progression free and overall survival. In 2024, the FDA consensus is that MRD negativity can be used as a clinical trial endpoint. This shift is driving innovation [...]