AbbVie’s headquarters in September 2024. Photo: LittleT889 via Wikimedia Commons, CC BY 4.0. Resized.
AbbVie said Tuesday it has asked U.S. regulators to approve etentamig, an experimental treatment for adults whose multiple myeloma has returned or stopped responding to treatment, bringing a once-monthly infusion closer to a possible place in the blood-cancer market.
The filing is an application, not an approval. In its announcement, AbbVie did not give an FDA decision date, a launch date or a price. Etentamig remains investigational.
The company’s case rests on a late-stage study that compared the drug with physicians’ choice of available treatments in patients who had already received at least two treatment regimens and been exposed to three major classes of myeloma medicines.
A new option for heavily treated patients
Multiple myeloma affects plasma cells, a type of white blood cell in the bone marrow. As the cancer returns after treatment, patients and doctors can face a shrinking set of options. AbbVie’s application targets that relapsed or treatment-resistant setting, rather than newly diagnosed patients.
Etentamig is a bispecific antibody, meaning it binds to two targets. It is designed to connect a marker called BCMA on myeloma cells with CD3 on immune-system T cells, helping those immune cells attack the cancer.
That approach belongs to a treatment category that already includes BCMA-directed antibodies and cell therapies. AbbVie is seeking to distinguish its drug partly through an intravenous dosing schedule that uses one step-up dose followed by treatment every four weeks from initiation.
The company says that schedule could support delivery in a wider range of care settings, including community care. That is a proposed benefit, not a guarantee that every patient could receive treatment locally or avoid monitoring.
Stronger response results, with significant risks
In the randomized, open-label CERVINO trial, 393 patients received either etentamig or one of several standard regimens, according to AbbVie. The company reported an overall response rate of 74%, compared with 45.7% for the comparison treatments.
It also reported a 60% reduction in the risk of disease progression or death, the study’s progression-free-survival measure. That figure does not mean patients lived 60% longer or that the trial established an overall-survival benefit. The announcement did not provide median progression-free-survival times or overall-survival results.
The safety findings complicate a simple account of the treatment’s benefits. Serious grade 3 or 4 infections occurred in 27.7% of etentamig patients, compared with 19.2% of patients receiving the standard treatments. Fatal infections occurred in 1.5% and 3.1%, respectively, AbbVie said.
Other common treatment-emergent problems included cytokine release syndrome, low antibody levels, low neutrophil counts and anemia. Cytokine release syndrome is an inflammatory reaction associated with immune-activating cancer treatments.
Among patients receiving a single step-up dose, AbbVie reported cytokine release syndrome in 28.3%, all classified as grade 1 or 2, with no grade 3 or higher cases in that group. One patient had a grade 1 immune-cell-associated neurological event. Those findings do not eliminate the need to weigh infection, immune and neurological risks.
Discontinuations linked to treatment-emergent adverse events were 3.6% with etentamig and 14% with the comparison therapies, according to the company. The figures come from AbbVie’s report of the trial, which it said was presented at the International Myeloma Society’s 2026 meeting.
For AbbVie, the application advances its effort to build a broader multiple-myeloma business. For patients, the practical questions remain regulatory approval, the eventual treatment label, monitoring requirements, access and cost. Tuesday’s filing moves that process forward without settling those questions.
JBizNews Desk | North Chicago
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