Sagar Lonial, MD, FACP, FASCO, and Sikander Ailawadhi, MD, discuss the investigation of cemsidomide in relapsed/refractory multiple myeloma.
News|Articles|February 10, 2026
- Vol.27/No.4
- Volume 27
- Issue 4
FDA Guidance Signals Shift Toward MRD-Driven Accelerated Approvals in Multiple Myeloma
Author(s)Chris Ryan
Fact checked by: Jax DiEugenio, Ron Panarotti
Experts break down the FDA’s draft guidance on the use of MRD end points to support accelerated drug approvals in multiple myeloma.
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More than 20 new drugs or biological products have been approved for the treatment of multiple myeloma since 2003, translating to improved response rates and long-term outcomes across the treatment continuum.1 However, the integration of novel treatment strategies and combinations has added complexity to trials evaluating newer drugs and treatments, with longer-term follow-up required to properly assess end points such as progression-free survival (PFS) and overall survival (OS).
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