DARZALEX FASPRO® is the first and only treatment approved by the U.S. FDA for patients with high

Phase 3 AQUILA study showed DARZALEX FASPRO ® significantly reduced the risk of progression to active multiple myeloma or death by 51 percent compared to active monitoring

Landmark approval supports earlier intervention and disease interception of multiple myeloma for the first time

HORSHAM, Pa. , Nov. 6, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) today announced the U.S. Food and Drug Administration (FDA) approved DARZALEX FASPRO ® (daratumumab and hyaluronidase-fihj) as a single agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM). 1 DARZALEX FASPRO ® is the first and only approved treatment for HR-SMM, enabling earlier intervention before the disease progresses to active multiple myeloma.

FDA approval is based on findings from