FDA Advisory Committee Supports DARZALEX FASPRO® for High-Risk Smoldering Multiple Myeloma Treatment

FDA Advisory Committee Votes for DARZALEX FASPRO®

On May 20, 2025, Johnson & Johnson announced a significant regulatory advancement regarding the treatment of high-risk smoldering multiple myeloma (HR-SMM). The U.S. FDA's Oncologic Drugs Advisory Committee (ODAC) cast a 6-2 vote favoring the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), marking a pivotal moment for patient care in this area.

Implications of ODAC's Vote

The recommendation could reshape treatment approaches for high-risk patients, who have a high probability of progressing to active multiple myeloma (MM) within a few years. It emphasizes the necessity for timely therapeutic intervention, moving away from the traditional “Watch and Wait” strategy often adopted in such cases.

Currently, there are no FDA-approved therapies specifically targeting HR-SMM. In 2024, estimates indicated over 35,000 new cases of MM in the U.S., with around 15% classified as smoldering. Approximately 50% of individuals diagnosed with HR-SMM can expect to transition to active disease within two to three years, highlighting the urgency for innovative treatment solutions.

The AQUILA Study and Its Findings

The ODAC's support was largely informed by the AQUILA study, a Phase 3, randomized trial that compared DARZALEX FASPRO® against the standard of care active monitoring in patients with HR-SMM. The study showcased promising results, demonstrating a positive impact on progression-free survival and overall clinical benefits for participants. Key findings were presented at the American Society of Hematology (ASH) Annual Meeting in 2024 and published in The New England Journal of Medicine.

Dr. Sen Zhuang, Vice President of Oncology Clinical Research at Johnson & Johnson, remarked, "Early intervention in high-risk smoldering multiple myeloma has demonstrated a reduction in the risk of progression or death. This proactive approach we are advocating is an embodiment of our commitment to tackling cancer head-on."

The Future of Myeloma Treatment

Peter Voorhees, a leading oncologist at Atrium Health, highlighted the therapeutic gap in managing HR-SMM. He stated, "Addressing the challenges presented by high-risk smoldering multiple myeloma is critical. The promise of DARZALEX FASPRO® could delay or potentially prevent the transition into active myeloma, which is why the ODAC’s affirmation is so vital."

Johnson & Johnson's future vision for oncology reflects a paradigm shift; prioritizing earlier diagnosis and earlier treatment interventions. Should the FDA grant approval based on ODAC's recommendations, DARZALEX FASPRO® would stand as a transformative option within a therapeutic landscape that is currently limited for HR-SMM.

What’s Next?

While the ODAC plays a key role in evaluating the safety and efficacy of oncology products, their recommendations are advisory and not binding. The final decision on the approval will ultimately rest with the FDA, which is responsible for ensuring the public's safety and high standards for healthcare products.

In conclusion, the support for DARZALEX FASPRO® by the FDAs advisory committee is not just a step forward for Johnson & Johnson, but a beacon of hope for countless individuals facing the challenges posed by high-risk smoldering multiple myeloma. Advancements in treatment could significantly alter patient outcomes, emphasizing the need for proactive management in the journey against multiple myeloma.