Johnson & Johnson’s (J&J) blockbuster oncology asset, Darzalex Faspro (daratumumab and hyaluronidase-fihj) has gained US approval in smouldering multiple myeloma (sMM).
J&J’s CD38-targeting monoclonal antibody (mAb) is now indicated for use in adult patients with high-risk sMM, meaning patients will have access to a treatment option before progression into active disease.
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This makes it the first drug to ever get the US Food and Drug Administration (FDA) go-ahead in the smouldering population.
Darzalex secured FDA approval based on the results of the Phase III AQUILA trial (NCT03301220), which saw the drug significantly improve progression-free survival (PFS) over the ‘watch and wait’ method, which is currently the standard of care (SoC) protocol for sMM.
The subcutaneous drug also reduced the risk of disease progression or death by 51% compared with active monitoring, which Jordan Schecter, J&J Innovative Medicines’ VP of R&D for oncology, noted could “improve outcomes for patients at every stage of their disease”.
The most common treatment-related adverse events (TRAEs) associated with Darzalex Faspro as a monotherapy in the AQUILA study were diarrhoea, fatigue, musculoskeletal pain, rash, sleep disorders, and upper respiratory tract infection, as well as sensory neuropathy and injection site reactions.
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By GlobalDataTreatment versus monitoring: weighing up the benefits
Schecter stated that Darzalex Faspro could “shift the treatment paradigm” for multiple myeloma (MM), which has traditionally been approached only when patients progress from smouldering to active disease.
GlobalData oncology and haematology analyst Biswajit Podder echoed this sentiment, adding that it will achieve this in a “focused way”.
He said: “For truly high-risk patients, it offers a real chance to delay progression and organ damage with a convenient subcutaneous option, using a drug with a well-known safety profile.”
However, Podder notes that there are some caveats to consider. This includes the multi-year nature of the therapy, its associated infection risk, and the need for careful selection and monitoring of patients on the drug.
According to the analyst, the necessity of patient monitoring means that “shared decision-making between healthcare professionals and patients will be key”.
Darzalex’s future market impact
Now that Darzalex has been approved in the sMM population, it covers ten indications across the MM treatment landscape, of which four are in the front-line setting.
It is also approved for use in combination with bortezomib, cyclophosphamide and dexamethasone in newly diagnosed, light-chain (AL) amyloidosis, making it the first targeted therapy to obtain approval for this indication.
Due to its widespread role in multiple myeloma, Darzalex has become a best-seller for J&J, pulling in $3.6bn for the company in Q3 2025 alone. According to a GlobalData report, the drug will also be one of four major drivers for the market’s growth up to 2032.
GlobalData is the parent company of Pharmaceutical Technology.
Podder noted that Darzalex’s approval in the sMM indication pulls the drug further upstream, which will “increase overall exposure and reinforce J&J’s dominance across the myeloma continuum” – setting a benchmark competitors must beat.
However, Podder caveats that the strict high-risk criteria and payer controls may gate Darzalex’s future uptake in sMM.
Analysts at GlobalData forecast that sales of Darzalex will peak at $16.8bn in 2029. From this point onwards, they will decline, hitting a value of $15.5bn in 2031.
