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J&J's DARZALEX FASPRO® Wins FDA Approval to Becomes First Therapy for High-Risk Smoldering Multiple Myeloma
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A landmark approval was announced by Johnson & Johnson from the U.S. Food and Drug Administration (FDA) for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) as the first and only single-agent treatment for adult patients with high-risk smoldering multiple myeloma (HR-SMM), enabling earlier intervention before the disease progresses to active multiple myeloma.

Smoldering multiple myeloma is an asymptomatic precursor malignancy that shares the same genomic makeup as active multiple myeloma, an incurable blood cancer, and historically, the standard of care for HR-SMM patients—of which an estimated 50 percent are likely to progress to active disease within two years—has been active monitoring, or "Watch and Wait." This paradigm-shifting approval is supported by findings from the Phase 3 AQUILA study (NCT03301220), the largest trial ever conducted in HR-SMM, which demonstrated a significant improvement in the primary endpoint of progression-free survival (PFS).

Specifically, DARZALEX FASPRO® reduced the risk of progression to active multiple myeloma or death by 51 percent compared to active monitoring. Over a median follow-up of 65.2 months, 63.1 percent of patients receiving the treatment had not progressed to active myeloma at 5 years, versus only 40.7 percent in the active monitoring group (HR, 0.49; P<0.001). Furthermore, patients on DARZALEX FASPRO® saw a substantially higher overall response rate of 63.4 percent compared to 2.0 percent, and the median time to receiving first-line multiple myeloma treatment was significantly delayed to not reached (NR) for the treatment arm versus 50.2 months for active monitoring. According to clinicians, this approval underscores the vital role of early disease intervention, finally offering a therapeutic option instead of just tracking signs of progression. DARZALEX FASPRO®, which is the only subcutaneous CD38-directed antibody approved for multiple myeloma, was generally well-tolerated in the AQUILA study, with adverse reactions consistent with previous trials, the most common being upper respiratory tract infection, musculoskeletal pain, fatigue, diarrhea, rash, sleep disorder, sensory neuropathy, and injection site reactions.

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