FDA Proposes Accelerated Approval for Multiple Myeloma Drugs

New draft guidance aims to speed up approvals using minimal residual disease and complete response as endpoints.

Published on Feb. 12, 2026

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The FDA has issued a draft guidance proposing the use of minimal residual disease (MRD) and complete response rates as primary trial endpoints to accelerate the approval of new multiple myeloma drugs. The agency says this will help expedite the availability of promising therapies as recent trials have seen high overall response rates, making it difficult to demonstrate statistically significant differences. However, one expert is skeptical about industry compliance with the proposed recommendations.

Why it matters

The proposed changes are intended to safely accelerate the approval process for new multiple myeloma treatments, which have seen significant advancements in recent years. MRD is considered a more sensitive efficacy measure than overall response rate. However, there are concerns that pharmaceutical companies may not fully comply with the guidance, potentially undermining the intent to provide faster access to effective therapies.

The details

The draft guidance recommends using MRD negativity rate and complete response as primary endpoints for accelerated approval, as these measures have demonstrated correlations with progression-free and overall survival. The FDA says this will help expedite approvals as recent trials have seen high overall response rates, making it difficult to show statistically significant differences. The guidance also covers not using these endpoints in maintenance settings or for smoldering myeloma trials.

  • The FDA issued the draft guidance on February 12, 2026.
  • The public comment period for the draft guidance is open until March 23, 2026.

The players

FDA

The U.S. Food and Drug Administration, the federal agency responsible for regulating and supervising the safety of food, drugs, and other products.

Manni Mohyuddin, MD

A multiple myeloma expert at the University of Utah Huntsman Cancer Institute in Salt Lake City.

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What they’re saying

“MRD is a 'good surrogate' for progression-free survival. But he noted that progression-free survival does not always correlate with overall survival in myeloma.”

— Manni Mohyuddin, MD, Multiple myeloma expert (Medscape Medical News)

“If followed appropriately, the FDA's proposed recommendations provide 'enough guardrails for safe use' of MRD as an endpoint.”

— Manni Mohyuddin, MD, Multiple myeloma expert (Medscape Medical News)

“Unfortunately, the past predicts for the future, and I suspect in myeloma, industry will continue to use unethical control arms and poor postprotocol therapy.”

— Manni Mohyuddin, MD, Multiple myeloma expert (Medscape Medical News)

What’s next

The FDA's draft guidance is open for public comments until March 23, 2026. Once finalized, the guidance will provide specific recommendations for designing clinical trials with an MRD endpoint.

The takeaway

The FDA's proposed changes aim to accelerate the approval of promising new multiple myeloma treatments by using more sensitive efficacy measures like minimal residual disease. However, concerns remain about whether pharmaceutical companies will fully comply with the guidance, potentially undermining the intent to provide faster access to effective therapies.