North Chicago, Illinois, USA, October 27, 2026
AbbVie has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking approval of etentamig (ABBV-383) for adults with relapsed or refractory multiple myeloma, a blood cancer that affects plasma cells in the bone marrow. The investigational medicine is a second-generation BCMA × CD3 bispecific antibody T-cell engager designed to direct immune cells toward cancer cells. The submission is supported by results from the Phase 3 CERVINO clinical trial, which demonstrated statistically significant improvements in overall response rate and progression-free survival compared with standard available therapies. The application marks an important regulatory milestone for AbbVie as it seeks to expand treatment options for people whose multiple myeloma has returned or stopped responding to previous treatments. Etentamig remains investigational and is not yet approved for commercial use.
Phase 3 CERVINO Trial Demonstrates Clinical Benefit
The BLA submission is based on the global, randomized, open-label Phase 3 CERVINO study, which evaluated etentamig against investigator-selected standard available therapies in patients with triple-class-exposed relapsed or refractory multiple myeloma. Participants had received at least two previous lines of treatment, including exposure to a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 monoclonal antibody. The trial enrolled 393 patients, randomized to receive etentamig or one of the available standard treatment regimens. According to AbbVie, etentamig achieved an overall response rate of 74.0%, compared with 45.7% among patients receiving standard therapies. The study also reported a 60% reduction in the risk of disease progression or death, demonstrating a statistically significant improvement in progression-free survival. These findings support further regulatory evaluation of etentamig in a patient population with substantial unmet medical needs. However, the results reflect the specific population and treatment comparisons used in CERVINO and should not be interpreted as proof that the medicine will benefit every patient with multiple myeloma.
BCMA-Targeted Therapy Uses the Immune System
Etentamig is designed to bind B-cell maturation antigen (BCMA) on multiple myeloma cells and CD3 on T cells, bringing immune cells into proximity with malignant plasma cells to support targeted immune activity. BCMA is an established therapeutic target in multiple myeloma because it is highly expressed on malignant plasma cells. AbbVie has designed etentamig with a low-affinity CD3-binding domain and a high-affinity, bivalent BCMA-binding domain. The investigational antibody also retains FcRn binding, supporting a dosing approach intended to enable monthly administration after a single step-up dose. This schedule could offer practical advantages for treatment delivery if approved, including the potential to support use across a broader range of care settings. Despite advances in BCMA-directed therapies, treatment can be complicated by adverse events such as cytokine release syndrome (CRS), infections and neurotoxicity, as well as requirements for specialized monitoring. Etentamig’s safety and dosing profile will therefore remain important considerations as regulators assess the application.
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Safety Findings and Regulatory Next Steps
In the CERVINO study, commonly reported treatment-emergent adverse events with etentamig included cytokine release syndrome, hypogammaglobulinemia, neutropenia and anemia. Among patients receiving the single step-up dose, CRS occurred in 28.3%; reported cases were Grade 1 or Grade 2, with no Grade 3 or higher CRS events in that group. One patient experienced a Grade 1 immune effector cell-associated neurotoxicity syndrome event. Grade 3 or 4 infections occurred in 27.7% of etentamig-treated patients, compared with 19.2% in the standard-therapy group, while Grade 5 infections were reported in 1.5% and 3.1%, respectively. Treatment-emergent adverse-event-related discontinuations were reported in 3.6% of patients receiving etentamig versus 14% receiving standard available therapies. These findings provide context for evaluating both the potential benefits and risks of treatment. The FDA will review the submitted evidence to determine whether etentamig meets the requirements for approval. The BLA submission does not guarantee regulatory authorization, and additional information or regulatory actions may be required before a decision. If approved, etentamig could become another option for adults with heavily pretreated multiple myeloma, an area where durable disease control and manageable treatment delivery remain important clinical priorities.
Source: AbbVie press release
