AbbVie Files BLA With FDA for Etentamig in Relapsed/Refractory Myeloma

AbbVie announced on October 27, 2026, that it has submitted a biologics license application (BLA) to FDA for etentamig (ABBV-383), an investigational second-generation B-cell maturation antigen (BCMA) x CD3 bispecific antibody T-cell engager, for adults with relapsed or refractory multiple myeloma.¹ The intravenously administered therapy is given monthly after a single step-up dose, and the submission is supported by the phase 3 CERVINO trial.¹

"Patients deserve therapeutic options that are not only effective, but also support the realities of when, where and how they receive treatment," said Daejin Abidoye, MD, vice president and therapeutic area head, oncology, solid tumor and hematology, AbbVie, in a company press release.¹

What did the CERVINO trial show?

The global, multicenter, randomized, open-label CERVINO trial (NCT06158841) compared etentamig with investigator's choice of standard available therapies (SAT) in 393 patients with triple-class exposed relapsed or refractory multiple myeloma who had received at least 2 prior lines of therapy.¹^,² SAT options were carfilzomib plus dexamethasone, elotuzumab plus pomalidomide and dexamethasone, or selinexor plus bortezomib and dexamethasone.¹

Etentamig met both dual primary endpoints. The overall response rate was 74.0% with etentamig vs 45.7% with SAT, and the therapy reduced the risk of disease progression or death by 60%.¹ In topline results announced on September 3, 2026, AbbVie reported a PFS hazard ratio of 0.40 (95% confidence interval, 0.29-0.54; p<.0001).³ Key secondary endpoints include overall survival, depth of response, measurable residual disease negativity, disease symptoms, and physical functioning.¹

How safe was etentamig with monthly dosing?

The most common treatment-emergent adverse events (TEAEs), occurring in at least 25% of etentamig-treated patients, were cytokine release syndrome (CRS), hypogammaglobulinemia, neutropenia, and anemia.¹ Discontinuations related to TEAEs occurred in 3.6% of patients receiving etentamig vs 14% receiving SAT.¹

Among patients receiving a single step-up dose, CRS occurred in 28.3%. All CRS events were grade 1 (23.9%) or grade 2 (4.4%), with no grade 3 or higher events.¹ One patient had a grade 1 immune effector cell-associated neurotoxicity syndrome event. Grade 3 or 4 infections occurred in 27.7% of etentamig-treated patients vs 19.2% of those receiving SAT. Grade 5 infections occurred in 1.5% vs 3.1%, respectively.¹

Why does etentamig's design matter for myeloma care?

BCMA-directed bispecific antibodies and chimeric antigen receptor T-cell therapies have changed multiple myeloma treatment. According to AbbVie, however, their wider use may be limited by CRS, infections, neurotoxicity, and specialized administration and monitoring requirements.¹ The company positions etentamig as a potential option for a broad range of settings, including community-based care.¹

Etentamig combines a low-affinity CD3 binding domain designed to reduce CRS and infections, a high-affinity bivalent BCMA-binding domain, and retained FcRn binding enabling dosing every 4 weeks.¹ The molecule was first evaluated in a phase 1 first-in-human study in patients with relapsed or refractory multiple myeloma.⁴ AbbVie noted that the direct connection between these structural features and clinical effects is still being investigated.¹

What are the limitations?

BLA submission does not guarantee FDA acceptance or approval, and AbbVie did not disclose whether it requested priority review or a target action date. CERVINO was open label, and full results have not been published in a peer-reviewed journal. The SAT discontinuation rate reported in the BLA announcement (14%) differs from the 9.6% reported with topline results.^1,3 Overall survival had not crossed its prespecified efficacy boundary at the topline data cutoff.³ Grade 3 or 4 infections were more frequent with etentamig than with SAT.

References

1. AbbVie. AbbVie submits biologics license application (BLA) for etentamig to U.S. FDA for adults living with relapsed/refractory multiple myeloma. Press release. Published October 27, 2026. Accessed October 28, 2026. https://news.abbvie.com/2026-10-27-AbbVie-Submits-Biologics-License-Application-BLA-for-Etentamig-to-U-S-FDA-for-Adults-Living-With-Relapsed-Refractory-Multiple-Myeloma
2. Study assessing activity of intravenous (IV) etentamig monotherapy versus standard available therapies in adult participants with relapsed or refractory multiple myeloma (CERVINO). ClinicalTrials.gov; NCT06158841. Updated August 27, 2026. Accessed October 28, 2026. https://clinicaltrials.gov/study/NCT06158841
3. AbbVie. AbbVie announces positive topline results from the Phase 3 CERVINO trial showing etentamig significantly improved response rate and progression-free survival in patients with relapsed/refractory multiple myeloma. Press release. Published September 3, 2026. Accessed October 28, 2026. https://news.abbvie.com/2026-09-03-AbbVie-Announces-Positive-Topline-Results-from-the-Phase-3-CERVINO-Trial-Showing-Etentamig-Significantly-Improved-Response-Rate-and-Progression-Free-Survival-in-Patients-with-Relapsed-Refractory-Multiple-Myeloma
4. D'Souza A, Shah N, Rodriguez C, et al. A phase I first-in-human study of ABBV-383, a B-cell maturation antigen × CD3 bispecific T-cell redirecting antibody, in patients with relapsed/refractory multiple myeloma. J Clin Oncol. 2022;40(31):3576-3586. doi:10.1200/JCO.22.01504