In Regulatory First, Myeloma Drug Approved Based on MRD Negativity.

The FDA has approved iberdomide for multiple myeloma based on minimal residual disease negativity, marking a first for the disease.

• Why it matters: This approval highlights a shift toward biomarker-based endpoints in drug regulation, addressing the need for more precise measures of treatment efficacy in multiple myeloma.
• What they did: The FDA approved iberdomide after demonstrating its effectiveness in achieving minimal residual disease negativity, utilizing this biomarker as a basis for approval.
• The result: This milestone may pave the way for future approvals of therapies based on minimal residual disease status and encourages development of targeted protein degraders.