FDA Receives BLA for Etentamig in R/R Multiple Myeloma

A biologics license application (BLA) has been submitted to the FDA, seeking the approval of etentamig (ABBV-383) for the treatment of adult patients with relapsed/refractory multiple myeloma.¹

The application is supported by data from the phase 3 CERVINO trial (NCT06158841), which met both of its dual primary end points of overall response rate (ORR) and progression-free survival (PFS).

Findings from CERVINO presented at the 23rd International Myeloma Society Annual Meeting showed that at a median follow-up of 11.4 months (range, 0.5-24.3), patients with triple-class exposed relapsed/refractory multiple myeloma treated with etentamig (n = 196) achieved an ORR of 74.0% vs 45.7% with investigator's choice of standard available therapy (SAT; difference, 28.3%; 95% CI, 18.49-37.46; P < .0001).² Additionally, the median PFS was not reached with etentamig vs 6.2 months with SAT, translating to a 60% reduction in the risk of disease progression or death (HR, 0.40; 95% CI, 0.29-0.54; P < .0001). The 12-month PFS rates were 62.1% vs 28.4%, respectively.

"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," Daejin Abidoye, MD, vice president and therapeutic area head, oncology, solid tumor and hematology, at AbbVie, said in a news release. "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."

How was CERVINO designed?

In the global, multicenter, open-label phase 3 CERVINO study, patients were randomly assigned to etentamig monotherapy or investigator's choice of standard available therapy.^2,3

Investigators enrolled patients at least 18 years of age with relapsed/refractory multiple myeloma who received at least 2 prior lines of therapy that included a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody; notably, only 1 prior line of therapy was required in the United States if patients received all 3 classes in the first line.³ No prior BCMA-directed therapy was permitted. Other key inclusion criteria comprised measurable disease, an ECOG performance status of 2 or lower, and eligibility for one of the comparator regimens.

In total, 393 patients were randomly assigned 1:1 to receive etentamig or investigator’s choice of SAT with carfilzomib (Kyprolis) plus dexamethasone, elotuzumab (Empliciti) plus pomalidomide (Pomalyst) and dexamethasone, or selinexor (Xpovio) plus bortezomib (Velcade) and dexamethasone.

ORR and PFS per independent review using International Myeloma Working Group response criteria served as the dual primary end points. Secondary end points included overall survival, depth of response, measurable residual disease negativity, duration of response, disease symptoms, and physical functioning.

What safety findings supported the submission?

Cytokine release syndrome (CRS), hypogammaglobulinemia, neutropenia, and anemia were the most common treatment-emergent adverse effects (TEAEs), each occurring in at least 25% of patients treated with etentamig.¹

In patients who received a single step-up dose, the rate of CRS was 28.3%, with all events limited to grade 1 (23.9%) or grade 2 (4.4%). A single patient had grade 1 immune effector cell–associated neurotoxicity syndrome.

Across the overall etentamig-treated population, grade 3 or 4 infections were reported in 27.7% of patients vs 19.2% of those given SAT; grade 5 infections occurred at rates of 1.5% and 3.1%, respectively. TEAEs led to treatment discontinuation in 3.6% of patients in the etentamig arm compared with 14% of patients in the control arm.

References

1. 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 27, 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. Voorhees P, Mateos MV, Costa L, et al. CERVINO: phase 3 results of etentamig vs investigator's choice of standard available therapies in patients with triple-class exposed relapsed or refractory multiple myeloma (RRMM). Presented at: 23rd International Myeloma Society (IMS) Annual Meeting & Exposition; September 23-26, 2026; Glasgow, Scotland. Abstract LBA-01.
3. Study assessing activity of intravenous (IV) etentamig monotherapy versus standard available therapies in adult participants with relapsed or refractory multiple myeloma (CERVINO). ClinicalTrials.gov. Updated August 27, 2026. Accessed October 27, 2026. https://clinicaltrials.gov/study/NCT06158841