The U.S. Food and Drug Administration (FDA) approved on Thursday Johnson & Johnson’s (NYSE:JNJ) Darzalex Faspro (daratumumab and hyaluronidase-fihj) for a type of blood cancer.

Darzalex Faspro is the first and only approved treatment for high-risk smoldering multiple myeloma (HR-SMM), enabling earlier intervention before the disease progresses to active multiple myeloma.

Smoldering multiple myeloma is an asymptomatic (no signs or symptoms) precursor state of active myeloma.

FDA approval is based on findings from the AQUILA study, which evaluated the efficacy and safety of Darzalex Faspro compared to active monitoring (or “Watch and Wait”) in the largest Phase 3 trial in patients with HR-SMM.

The AQUILA study demonstrated a significant improvement in the primary endpoint of progression-free ...