FDA Approves Darzalex Faspro for High-Risk Smoldering Multiple Myeloma
The FDA approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) as the first and only treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM) on November 6, 20251235.
Darzalex Faspro is a subcutaneous (under the skin) injection used as a single-agent therapy for HR-SMM, aiming to delay or prevent progression to active multiple myeloma1246789.
Approval was based on the phase 3 AQUILA study, which showed Darzalex Faspro reduced the risk of progression to active myeloma or death by 51% compared to active monitoring ("watch and wait") according to International Myeloma Working Group (IMWG) criteria211.
This marks a major change in the management of smoldering myeloma, as previous standard of care was observation without treatment until progression to active disease14.
Not all smoldering myeloma patients need early treatment; this approval applies specifically to those classified as high-risk1.
The FDA’s decision followed positive endorsement from the Oncologic Drugs Advisory Committee (ODAC) in May 2025 on the benefit-risk profile of Darzalex Faspro for this population2.
Sources:
1. https://themmrf.org/mmrf-blogs/darzalex-faspro-fda-approved-for-patients-with-high-risk-smoldering-myeloma/
2. https://www.prnewswire.com/news-releases/darzalex-faspro-is-the-first-and-only-treatment-approved-by-the-us-fda-for-patients-with-high-risk-smoldering-multiple-myeloma-302607893.html
3. https://www.prnewswire.com/news-releases/fda-approved-darzalex-faspro-for-adult-patients-with-high-risk-smoldering-multiple-myeloma-302608206.html
4. https://healthtree.org/myeloma/community/articles/daratumumab-for-high-risk-smoldering-myeloma
5. https://www.myeloma.org/news-events/multiple-myeloma-news/fda-approves-darzalex-faspro-daratumumab-hyaluronidase-fih-hr-smm
6. https://www.curetoday.com/view/fda-approves-darzalex-faspro-in-high-risk-smoldering-multiple-myeloma
7. https://sohoinsider.com/multiple-myeloma/fda-approves-darzalex-faspro/
8. https://www.targetedonc.com/view/fda-approves-subcutaneous-daratumumab-for-smoldering-multiple-myeloma
9. https://www.oncnursingnews.com/view/fda-approves-subcutaneous-daratumumab-in-high-risk-smoldering-myeloma
11. https://www.jnj.com/innovativemedicine/emea/darzalex-daratumumab-subcutaneous-formulation-shows-51-percent-reduction-in-risk-of-progression-to-active-multiple-myeloma-for-patients-with-high-risk-smouldering-multiple-myeloma