MRD as an early endpoint in myeloma and other hematologic malignancies: Implication for ongoing and future study designs - PubMed
5 hours ago
- #MRD
- #multiple myeloma
- #FDA approval
- MRD (Minimal/Measurable Residual Disease) is recognized as a highly sensitive biomarker for treatment response in multiple myeloma (MM).
- In 2024, the FDA accepted MRD-negative complete responses in MM as an early endpoint for accelerated approval of therapies.
- The article reviews the scientific and regulatory pathway leading to MRD's acceptance, including meta-analyses and regulatory engagement.
- MRD's role is explored in other hematologic malignancies like ALL, CLL, and AML, with disease-specific challenges noted.
- Innovative clinical trial designs using MRD may accelerate drug development and personalize therapy in hematologic oncology.