AbbVie Seeks FDA Approval of Etentamig in Relapsed/Refractory Multiple Myeloma

AbbVie has submitted a biologics license application (BLA) to the FDA for etentamig (ABBV-383, AbbVie), an investigational, intravenously administered B-cell maturation antigen (BCMA)  x CD3 bispecific antibody T-cell engager, for the treatment of adults with relapsed or refractory multiple myeloma (RRMM), the company announced.

According to AbbVie, the second-generation agent combines a low-affinity CD3-binding domain, designed to reduce cytokine release syndrome (CRS) and infections, with a high-affinity bivalent BCMA-binding domain and retained neonatal Fc receptor (FcRn) binding that enables dosing every 4 weeks after a single step-up dose. The company added that it is still studying whether these structural features account for the clinical effects.

The submission is supported by the global, multicenter, randomized, open-label phase 3 CERVINO trial, which randomly assigned 393 patients with triple-class exposed RRMM and at least two prior lines of therapy to etentamig or investigator’s choice of standard available therapy (SAT). SAT options included carfilzomib plus dexamethasone, elotuzumab plus pomalidomide and dexamethasone, or selinexor plus bortezomib and dexamethasone. AbbVie reported statistically significant improvements with etentamig in both dual primary endpoints: overall response rate (74.0% vs 45.7%) and progression-free survival, for which the company reported a 60% risk reduction vs SAT. The release did not report a hazard ratio or confidence intervals.

The most common treatment-emergent adverse events (≥25%) with etentamig were CRS, hypogammaglobulinemia, neutropenia, and anemia. Among patients receiving a single step-up dose, CRS occurred in 28.3% (grade 1, 23.9%; grade 2, 4.4%), with no grade 3 or higher events; one patient had a grade 1 immune effector cell-associated neurotoxicity syndrome event. Grade 3/4 infections occurred in 27.7% of etentamig-treated patients vs 19.2% with SAT, and grade 5 infections in 1.5% vs 3.1%. Discontinuations related to adverse events occurred in 3.6% vs 14%.

The CERVINO data cited in the release come from an abstract presented at the 2026 International Myeloma Society Annual Meeting. Key secondary endpoints include overall survival, depth of response, measurable residual disease negativity, disease symptoms, and physical functioning; the release did not report results for these endpoints.

Source: AbbVie. AbbVie submits Biologics License Application (BLA) for etentamig to U.S. FDA for adults living with relapsed/refractory multiple myeloma. News release. AbbVie; October 27, 2026. Accessed October 28, 2026.