AbbVie files etentamig with FDA for relapsed or refractory multiple myeloma

What's the deal? AbbVie announced on 27 October 2026 that it has submitted a Biologics License Application (BLA) to the US FDA for etentamig, an intravenous bispecific antibody for adults with relapsed or refractory multiple myeloma - a blood cancer that has returned or stopped responding to earlier treatments. The filing is backed by the global Phase 3 CERVINO study, in which etentamig improved overall response rate (74.0% vs 45.7%) and cut the risk of disease progression or death by 60% versus investigator's choice of standard therapies in patients who had already been exposed to three main treatment classes.

Why it matters: Etentamig is a second-generation "T-cell engager": a single engineered antibody that hooks a patient's immune T-cells onto myeloma cells by binding both the BCMA protein on the tumour and CD3 on T-cells, forcing the immune system to destroy the cancer. The developer notes its monthly dosing schedule and low rate of severe cytokine release syndrome (an immune overreaction) as potentially differentiating features for use in community care. AbbVie positions etentamig to broaden access to BCMA-targeted therapies beyond specialist centres; the company is also studying the drug in earlier lines of therapy.

Read more: AbbVie, 27 October 2026