SHERIDAN, WYOMING - November 10, 2025 - Johnson & Johnson has secured a major regulatory milestone for its oncology portfolio, with the U.S. Food and Drug Administration granting approval for Darzalex Faspro in patients with high-risk smoldering multiple myeloma. The expansion marks the first-ever therapy authorized for this pre-malignant stage of the disease, reinforcing J&J's leadership in hematologic oncology and enabling earlier clinical intervention to delay disease progression.
A Landmark Step Toward Early Intervention in Myeloma
Darzalex Faspro's new indication targets adults with high-risk smoldering multiple myeloma-patients statistically more likely to develop active disease within two years of diagnosis. By offering the first approved option at this pre-symptomatic stage, J&J is advancing a proactive "disease interception" approach that could reshape treatment timelines for oncologists and hematology practices.
Backed by robust evidence from the Phase III AQUILA trial, which enrolled nearly 400 participants, the therapy demonstrated a 51% overall reduction in disease progression compared with active monitoring alone. Among high-risk patients, the benefit increased to 64%, while overall survival improved by 48%-a set of results that prompted strong regulatory support.
Clinical Validation Through the AQUILA Study
AQUILA's design compared subcutaneous Darzalex Faspro against traditional "watch and wait" protocols, which have long been the standard for smoldering multiple myeloma. Data presented in late 2024 showed that early intervention significantly prolonged progression-free survival, positioning the therapy as a first-line preventive tool for hematologists managing high-risk patient cohorts.
In May 2025, the FDA's Oncologic Drugs Advisory Committee voted 6-2 in favor of approval, validating the strength of the clinical evidence while encouraging continued monitoring of long-term safety data.
Mechanism and Broader Oncology Context
Administered under the skin, Darzalex Faspro is a monoclonal antibody that targets the CD38 protein, found on plasma cells involved in the pathogenesis of multiple myeloma. By binding to CD38, it blocks cancer cell growth and induces cell death through immune-mediated pathways. The therapy already holds multiple FDA approvals across relapsed and refractory multiple myeloma and light chain amyloidosis indications, cementing its role as a cornerstone of J&J's oncology business.
Last year, Darzalex Faspro generated $11.6 billion in global sales, accounting for more than half of J&J's cancer revenues. During the third quarter of 2025, the drug brought in $3.6 billion, reflecting nearly 20% year-over-year growth-a testament to its continued clinical uptake and expanding global footprint.
Quote: J&J Leadership Highlights Strategic Value
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"The approval enables earlier intervention and disease interception," Johnson & Johnson said in its announcement Thursday, emphasizing that the decision supports the company's broader strategy to expand its oncology presence through precision immunotherapy.
Competitive and Regulatory Landscape
The label expansion arrives amid renewed momentum in the multiple myeloma market. Just weeks earlier, the FDA reinstated GSK's antibody-drug conjugate Blenrep for third-line myeloma treatment, reversing a prior withdrawal despite an earlier negative advisory vote. Experts such as Dr. Neil Vasan of Columbia University Medical Center, who voted against Blenrep's approval, underscored the ongoing debate over balancing efficacy and toxicity in next-generation myeloma therapies: "The efficacy data were strong but the toxicity data were also very strong."
These developments illustrate a competitive and fast-evolving environment where differentiated mechanisms-such as J&J's CD38-targeted platform-remain central to clinical and commercial success.
Strategic Implications for Oncology Providers
For hematology centers and oncology networks, the new indication for Darzalex Faspro introduces an evidence-backed option for delaying disease progression before the onset of symptomatic myeloma. This may lead to earlier patient stratification protocols, enhanced risk monitoring, and increased demand for in-clinic subcutaneous administration infrastructure.
From a business standpoint, J&J's expansion reinforces the durability of its oncology franchise, supporting investor confidence amid broader market volatility in biotech.
Learn More
For further insights into the evolving landscape of hematologic oncology and early-intervention therapies, visit fairsonline.org/biotech-research-outlook.