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# FDA OKs Darzalex Faspro for Smoldering Multiple Myeloma
- URL: https://www.fdaweb.com/fda-oks-darzalex-faspro-for-smoldering-multiple-myeloma/
- Published: 2025-11-07T12:00:00.000Z
- Updated: 2026-09-14T15:26:04.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160182

FDA has approved Janssen’s Darzalex Faspro (daratumumab and hyaluronidase-fihj, Janssen Biotech) for adults with high-risk smoldering multiple myeloma (SMM), marking the first approved therapy for this early stage of the blood cancer. The decision is based on data from the Phase 3 AQUILA trial (NCT03301220), which compared Darzalex Faspro monotherapy to active monitoring in 390 patients with high-risk SMM. The study showed a 51% reduction in the risk of progression or death compared with patients under observation alone, an agency release says.

FDA says that high-risk SMM is defined by certain biological markers — such as serum monoclonal protein levels above 2 g/dL, a free light chain ratio greater than 20, or bone marrow plasma cells exceeding 20%. About 41% of participants in AQUILA met two or more of these criteria.

Darzalex Faspro combines the CD38-directed antibody daratumumab with hyaluronidase, an enzyme that enables rapid subcutaneous administration. As with other anti-CD38 therapies, Darzalex Faspro can interfere with blood typing and cross-matching tests.

Darzalex Faspro is already approved for several multiple myeloma indications, including newly diagnosed and relapsed or refractory disease, but this new indication extends its reach into pre-symptomatic, high-risk patients, aiming to delay full disease onset, according to the company.