FDA Drafts MRD-Based Path to Speed Myeloma Drug Approvals

The FDA released a draft guidance proposing minimal residual disease (MRD) and complete response (CR) as endpoints to support accelerated approvals for multiple myeloma. The document outlines trial design, timing, and MRD thresholds (MRD negativity at 10^-5, assessed around CR), with MRD potentially serving as an independent endpoint alongside CR, while noting MRD’s limitations—no use in maintenance or smoldering myeloma—and that the guidance is nonbinding. Issued after ODAC support but amid leadership changes, the guidance aims to speed access to new therapies (notably for CAR‑T and T‑cell engagers), though final approvals remain at the FDA’s discretion and unproven to guarantee OS benefits.