FDA Approves Darzalex Faspro for High-Risk Smoldering Multiple Myeloma, Based on Phase 3 AQUILA Trial
On November 6, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj (Darzalex Faspro) for the treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM).
The regulatory decision was supported by data from the Phase 3 AQUILA trial (NCT03301220). In May 2025, the FDA's Oncologic Drugs Advisory Committee had voted 6 to 2 in favor of the risk-benefit profile of subcutaneous daratumumab as monotherapy for high-risk smoldering multiple myeloma, based on AQUILA.
Smoldering multiple myeloma is an asymptomatic precursor stage of multiple myeloma, and patients classified as high-risk face a greater likelihood of progressing to active disease. Darzalex Faspro was previously approved in several other multiple myeloma treatment settings, and this decision extends its indications further.
Source: U.S. Food and Drug Administration
Published by GSM · USA (original Chinese edition)
Photo: 图中是美国食品药品管理局（FDA）总部1号楼外观。Wikimedia Commons / U.S. Food and Drug Administration, Public domain
