HORSHAM, PA — Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration has approved DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) as the first-ever treatment for adults with high-risk smoldering multiple myeloma (HR-SMM), marking a major shift toward earlier intervention in the disease.
The approval is based on results from the Phase 3 AQUILA study, which showed DARZALEX FASPRO® reduced the risk of progression to active multiple myeloma or death by 51 percent compared to active monitoring. The trial is the largest of its kind in HR-SMM and demonstrated that patients treated with the therapy had significantly longer progression-free survival, with 63 percent remaining free of disease progression after five years.
“Until now, patients diagnosed with smoldering multiple myeloma only have the option to watch and wait for any active signs of progression to active disease,” said Dr. Peter Voorhees of Atrium Health’s Levine Cancer Institute in Charlotte, North Carolina. “Results from AQUILA demonstrated DARZALEX FASPRO significantly delayed disease progression, highlighting the role of early intervention for patients with high-risk smoldering multiple myeloma.”
The FDA’s decision follows a May 2025 vote by the agency’s Oncologic Drugs Advisory Committee supporting the therapy’s benefit-risk profile. With this approval, DARZALEX FASPRO® becomes the first and only FDA-approved treatment for HR-SMM, providing patients and clinicians a new option to intercept the disease before it advances.
“DARZALEX FASPRO is a foundational therapy in multiple myeloma and illustrates our commitment to improving outcomes for patients at every stage of their disease,” said Dr. Jordan Schecter, vice president of Research & Development, Multiple Myeloma, at Johnson & Johnson Innovative Medicine. “With today’s approval, patients with HR-SMM will now be able to receive this treatment before they progress to active multiple myeloma, giving us the opportunity to shift the treatment paradigm.”
Smoldering multiple myeloma, an asymptomatic precursor to active disease, accounts for about 15 percent of all multiple myeloma cases. Roughly half of patients diagnosed with the high-risk form are likely to develop active myeloma within two years. Until now, standard care for these patients has been active monitoring, commonly known as “watch and wait.”
Adverse reactions observed in the AQUILA study were consistent with prior DARZALEX FASPRO® research, with the most common side effects including fatigue, rash, injection site reactions, and respiratory infections.
DARZALEX FASPRO® was first approved in 2020 and now carries ten FDA indications for multiple myeloma, four of which are for newly diagnosed patients. The treatment is co-formulated with Halozyme’s ENHANZE® drug delivery technology and represents one of the most widely used subcutaneous therapies in the field.
The approval marks a pivotal milestone in multiple myeloma treatment—offering patients at high risk of progression a chance to act before the disease becomes symptomatic and potentially reshaping the standard of care for years to come.
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