On May 20, 2025, Johnson & Johnson announced a significant milestone in the treatment of high-risk smoldering multiple myeloma (HR-SMM).

The U.S. Food and Drug Administration’s Oncologic Drugs Advisory Committee (ODAC) voted 6-2 in favor of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) as a single-agent therapy for adults with HR-SMM. If approved, DARZALEX FASPRO would become the first therapy available to delay—or potentially prevent—progression to active multiple myeloma.

The committee’s recommendation is based on data from the pivotal Phase 3 AQUILA study, which demonstrated a meaningful progression-free survival benefit in patients treated with DARZALEX FASPRO compared to those under the current standard of care: active monitoring or “watch and wait.” Approximately 50% of individuals with HR-SMM progress to multiple myeloma within 2–3 years, often only receiving treatment after end-organ damage is detected.

This vote marks a possible paradigm shift in how clinicians approach early myeloma intervention. Currently, no treatments are FDA-approved for HR-SMM, despite the high risk of progression and lack of symptoms at diagnosis. DARZALEX FASPRO, already a foundational therapy in multiple myeloma, is poised to fill that unmet need.

“Early intervention in HR-SMM showed a reduction in the risk of progression or death,” said Dr. Sen Zhuang, Vice President, Oncology Clinical Research at Johnson & Johnson. “The AQUILA study demonstrates our commitment to stopping cancer before it starts.”

DARZALEX FASPRO has previously received FDA approval for multiple indications in multiple myeloma, including frontline and relapsed/refractory settings. It’s the only subcutaneous CD38-directed antibody available for treating the disease, offering patients a more convenient delivery method.

While the ODAC’s recommendation is non-binding, it strongly supports FDA approval. A final decision is expected later this year. If approved, DARZALEX FASPRO could transform care for thousands of patients annually diagnosed with HR-SMM in the U.S., offering a chance to act before irreversible complications occur.

Read the full press release from the button below.