U.S. FDA Oncologic Drugs Advisory Committee votes in favor of the benefit-risk profile of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for high-risk smoldering multiple myeloma

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ODAC recommendation based on the positive progression-free survival and clinical benefit in the Phase 3 AQUILA study

If approved, DARZALEX FASPRO® would be the first treatment to potentially delay or prevent progression to multiple myeloma

RARITAN, N.J., May 20, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE:JNJ) announced today the U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) voted (6-2) in favor of the benefit-risk profile of single-agent DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) for the treatment of adult patients with high-risk smoldering multiple myeloma (HR-SMM). An application for the approval of DARZALEX FASPRO® for adult patients with HR-SMM was submitted to the FDA in November 2024.

(PRNewsfoto/Johnson & Johnson)
(PRNewsfoto/Johnson & Johnson)

The vote highlights a pivotal moment in the care of patients most likely to develop active multiple myeloma (MM), potentially altering the course of disease and treatment. DARZALEX FASPRO® is a foundational therapy in MM, and if approved in this indication, would provide a potential path for earlier intervention.

No treatments are approved specifically to treat HR-SMM. In 2024, it was estimated that more than 35,000 people would be diagnosed with MM in the U.S., and approximately 15 percent of newly diagnosed MM cases are classified as smoldering. While patients diagnosed with HR-SMM are asymptomatic, approximately 50 percent are likely to develop active disease within two to three years. The current standard of care (SOC) for smoldering multiple myeloma (SMM), even those considered high-risk, is active monitoring ("Watch and Wait") until progression, which may lead to therapeutic intervention only after the detection of end-organ damage.

"Early intervention in high-risk smoldering multiple myeloma demonstrated a reduction in the risk of progression or death," said Sen Zhuang, M.D., Vice President, Oncology Clinical Research, Johnson & Johnson Innovative Medicine. "The proactive approach demonstrated in the AQUILA study is an example of Johnson & Johnson's aspiration to get in front of cancer by providing a platform to treat disease before progression to active disease."

The committee reviewed data from the AQUILA study, a Phase 3, randomized, open-label trial which evaluated the efficacy and safety of DARZALEX FASPRO® versus SOC active monitoring in patients with HR-SMM.1 Results were initially presented at the 2024 American Society of Hematology (ASH) Annual Meeting and simultaneously published in The New England Journal of Medicine.2