Updated 11/6/2025
The FDA has approved Darzalex Faspro® (a version of daratumumab given as an injection under the skin) for use in certain patients with high-risk smoldering multiple myeloma (SMM).
If you’ve been diagnosed with smoldering multiple myeloma—especially if you’ve been told you’re high-risk—you’ve likely wondered: Should I treat my smoldering disease right now, or wait until it becomes active myeloma?
This question has been at the center of ongoing scientific and clinical discussions. Earlier this year, the Oncologic Drugs Advisory Committee (ODAC)—a group of experts who advise the FDA on cancer treatment approvals—reviewed data from the AQUILA study, which evaluated whether early treatment with Darzalex Faspro could delay progression to active myeloma. Their input was part of the FDA’s deliberation leading up to this approval.
While earlier debate focused on interpreting the AQUILA results, the FDA has now completed its review and approved Darzalex Faspro for high-risk smoldering myeloma.
This approval means:
Not every person with smoldering myeloma will need or benefit from early treatment, and this is an important point to raise with your care team.
Whether to begin treatment or continue active observation depends on your individual situation. Key discussions with your healthcare provider may include:
Now that Darzalex Faspro is FDA-approved for high-risk smoldering myeloma, it is one option to consider, but not the only one.
Your care team can help you determine whether this treatment aligns with your goals, values, and medical needs.
You can also reach out to the MMRF Patient Navigation Center for support in understanding your risk and your options.
While FDA approval of Darzalex Faspro provides a new treatment option for some patients with high-risk smoldering myeloma, there are still important questions to answer.
Clinicians are continuing to learn how to best identify who is truly high-risk and most likely to benefit from early treatment, and who may be able to continue watching and waiting safely. More research and real-world experience will also help patients and providers better understand how to balance the potential benefits of delaying progression with the possible side effects of treatment.
The MMRF is committed to helping find these answers. Through our research collaborations, data resources, and the Multiple Myeloma Research Consortium® (MMRC®), we are working to improve risk assessment tools, expand clinical trial options, and provide patients with clear, easy-to-understand information.
Our goal is to ensure that every patient has the knowledge and support they need to make the treatment decision that feels right for them, in partnership with their healthcare team.
