In January 2026, the U.S. FDA issued draft guidance outlining how minimal residual disease (MRD) negativity in complete response may support accelerated approval in multiple myeloma. This guidance marks a meaningful shift for sponsors designing myeloma clinical programs.

This moderated panel discussion examines what the FDA guidance enables, what regulators can expect, and how MRD can be operationalized as a primary endpoint across trial design, assay validation, and regulatory strategy.

Three key take-aways

• Understand what the FDA’s MRD guidance means for accelerated approval pathways in multiple myeloma
• Recognize how trial design, endpoint timing, and assay validation influence regulatory confidence
• Learn practical steps that sponsors can take now to prepare MRD‑based programs for regulatory review

For more information and to register, click here.

Speakers:

Sari Heitner Enschede, MD
Head of Hematology, Senior Medical Strategy Lead, Hematology-Oncology Center of Excellence
IQVIA

Bradley Smith, PhD
Vice President Therapeutic Strategy, Drug Development and Regulatory Strategy
IQVIA

Franklin Sedarat, MD, MS
Global Director, Hematopathology
IQVIA Laboratories