AbbVie Submits Biologics License Application (BLA) for Etentamig to U.S. FDA for Adults Living With Relapsed/Refractory Multiple Myeloma

–  Etentamig is a second-generation BCMA-directed bispecific antibody T-cell engager with a clinical profile and dosing schedule that can potentially support treatment across a broad range of settings, including in community-based care
–  In the Phase 3 CERVINO study, etentamig achieved statistically significant improvements in overall response rate (ORR) and progression-free survival (PFS) versus investigator's choice of standard available therapies
–  Submission underscores AbbVie's ambition to advance a broad multiple myeloma portfolio that addresses disease complexity and supports patients' evolving care goals 

NORTH CHICAGO, Ill., Oct. 27, 2026 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for etentamig, a second-generation BCMA x CD3 bispecific antibody T-cell engager administered intravenously for the treatment of adults with relapsed or refractory multiple myeloma.¹

BCMA-directed bispecific antibodies and CAR-T therapies have significantly changed the treatment landscape for people living with multiple myeloma.² However, their broader adoption may be limited by adverse events such as cytokine release syndrome, infections or neurotoxicity, as well as specialized administration and monitoring requirements.^2,3,4 Additionally, as disease relapses, treatment options in later lines of therapy become increasingly limited. Together, these factors highlight the need for additional therapies that may address the biology of the disease and help support effective treatment delivery across diverse care environments.^2,3,4

"Multiple myeloma is a chronic blood cancer that can reshape a person's life. 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, M.D., vice president and therapeutic area head, oncology, solid tumor and hematology, AbbVie. "This milestone brings us a step closer to potentially delivering a novel, patient-centered treatment option with a manageable safety profile and the convenience of a monthly dosing schedule that can help meet the needs of people living with multiple myeloma wherever they receive care."

The submission is supported by results from the global, Phase 3, multicenter, randomized CERVINO study evaluating etentamig versus investigator's choice of standard available therapies (SAT) in patients with triple-class exposed relapsed or refractory multiple myeloma who had received at least two prior lines of therapy.⁵ Topline results were announced earlier this year.

• The findings indicated that etentamig achieved statistically significant improvements across the dual primary endpoints of overall response rate (74.0% vs. 45.7%) and progression-free survival (60% risk reduction) versus SAT.⁵
• The most common treatment-emergent adverse events (TEAEs) reported in the etentamig arm of the study (≥ 25%) included cytokine release syndrome (CRS), hypogammaglobulinemia, neutropenia and anemia.⁵
  • Discontinuations related to TEAEs were low for etentamig vs. SAT (3.6% vs. 14%).⁵
• With monthly dosing from initiation, etentamig demonstrated a potentially differentiated safety profile.⁵
  • Among patients receiving a single step-up dose, the incidence of CRS was low (28.3%), all being grade 1 (23.9%) or grade 2 (4.4%) and no grade 3 or higher events were reported.⁵ One patient experienced an immune effector cell-associated neurotoxicity syndrome (ICANS) event (grade 1).
  • Among all etentamig patients, grade 3/4 infections occurred in 27.7% versus 19.2% in patients receiving SAT.⁵ Importantly, grade 5 infections were observed less frequently in patients treated with etentamig (1.5%) versus SAT (3.1%).

About Multiple Myeloma

Multiple myeloma is a chronic blood cancer that affects white blood cells, called plasma cells, in the bone marrow.⁶ It causes these cells to grow and crowd out healthy cells that help fight infection.⁶ In 2025, an estimated 36,000 people were diagnosed with multiple myeloma in the U.S.⁷ The disease commonly presents with non-specific symptoms that may resemble other conditions, leading to delays in diagnosis and treatment.⁸ People living with multiple myeloma and their caregivers often face substantial physical, emotional and economic burden.⁹

About the Phase 3 CERVINO Study⁵

The Phase 3 CERVINO trial (NCT06158841) is a global, multicenter, randomized, open-label study evaluating etentamig versus investigator's choice of standard available therapies (SAT) in triple-class exposed patients with relapsed/refractory multiple myeloma (RRMM) who have received at least two prior lines of therapy, including exposure to a proteasome inhibitor, an immunomodulatory drug and an anti-CD38 monoclonal antibody. A total of 393 patients were randomized 1:1 to receive etentamig or SAT, including carfilzomib plus dexamethasone, elotuzumab plus pomalidomide and dexamethasone, or selinexor plus bortezomib and dexamethasone. Etentamig was administered using an optimized dosing strategy that incorporates a single step-up dose followed by monthly (Q4W) dosing from initiation.

The dual primary endpoints are overall response rate and progression-free survival. Key secondary endpoints include overall survival, depth of response, measurable residual disease (MRD) negativity, disease symptoms and physical functioning.

About Etentamig

Etentamig (ABBV-383) is an investigational, second-generation BCMA x CD3 bispecific antibody T-cell engager designed to combine meaningful anti-myeloma activity with a differentiated treatment experience for patients. Etentamig is composed of a low-affinity CD3 binding domain, designed to reduce cytokine release syndrome and infections, a high-affinity bivalent BCMA-binding domain, and retained FcRn binding enabling Q4W dosing after a single step-up dose. The direct connection between these structural findings and clinical effects is currently being investigated.¹⁰

BCMA is highly expressed on the surface of malignant plasma cells in multiple myeloma, making it a key target for therapy. BCMA plays a crucial role in the survival of myeloma cells by promoting their growth and inhibiting their apoptosis (programmed cell death).¹¹

Several clinical studies are evaluating the potential of etentamig across diverse patient populations and treatment settings. To learn more about AbbVie's ongoing etentamig clinical trials, please visit clinicaltrials.gov. 

About AbbVie in Oncology 

AbbVie is committed to elevating standards of care and bringing transformative therapies to patients worldwide living with difficult-to-treat cancers. We are advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumors. We are focusing on creating targeted medicines that either impede the reproduction of cancer cells or enable their elimination. We achieve this through various, targeted treatment modalities and biology interventions, including small molecule therapeutics, antibody-drug conjugates (ADCs), immuno-oncology-based therapeutics, multispecific antibodies and novel CAR-T platforms. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potential breakthrough medicines.

Today, our expansive oncology portfolio comprises approved and investigational treatments for a wide range of blood cancers and solid tumors. We are evaluating more than 35 investigational medicines in multiple clinical trials across some of the world's most widespread and debilitating cancers. As we work to have a remarkable impact on people's lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit http://www.abbvie.com/oncology.

About AbbVie 

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube. 

Forward-Looking Statements  

Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

References

1. AbbVie. Data on file ABVRRTI83865.
2. Hej-Ali S, Banwell K, Mohamed H, et al. Toxicities of CAR-T, bispecific antibodies, and antibody-drug conjugates in multiple myeloma: a practical approach to risk mitigation and management. Cancers (Basel). 2026;18(13):2083.
3. Benda M, Reimann P, Willenbacher W, et al. Infectious toxicities associated with bispecific antibodies and CAR-T cells in multiple myeloma: a systematic review. Ann Hematol. Published online June 18, 2026.
4. Graham T, Ackbarali T, Patel K, Richter J. Integrating bispecific antibodies into community myeloma care: challenges, insights, and educational impact. Blood. 2025;146(suppl 1):8134.
5. Voorhees P, Manteca V, Costa L, et al. "CERVINO: Phase 3 Results of Etentamig vs. Investigator's Choice of Standard Available Therapies in Triple-Class Exposed Relapsed or Refractory Multiple Myeloma (RRMM)." Abstract presented at International Myeloma Society Annual Meeting, 2026. Glasgow, Scotland.
6. Cleveland Clinic. Multiple Myeloma: Symptoms, Causes & Treatment. Updated August 18, 2025. Available at: https://my.clevelandclinic.org/health/diseases/6178-multiple-myeloma. Accessed October 2026.
7. American Cancer Society. Key Statistics About Multiple Myeloma. Last revised January 13, 2026. Available at: https://www.cancer.org/cancer/types/multiple-myeloma/about/key-statistics.html. Accessed October 2026.
8. Zorlu T, Kayer MA, Okumus N, et. al. Challenges, Difficulties, and Delayed Diagnosis of Multiple Myeloma. Diagnostics (Basel). 2025 Jul 4;15(13):1708.
9. Gatopoulou X, Iraqi W, Morgan K, et. al. The Burden of a Multiple Myeloma Diagnosis on Patients and Caregivers in the First Year: Western European Findings. Clinicoecon Outcomes Res. 2022 Dec 17;14:731-753.
10. 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.
11. Graham T, Ackbarali T, Patel K, Richter J. Integrating bispecific antibodies into community myeloma care: challenges, insights, and educational impact. Blood. 2025;146(suppl 1):8134.

SOURCE AbbVie