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AbbVie's monthly bispecific antibody etentamig is one step closer to FDA approval. The company submitted a biologics license application (BLA) backed by phase 3 CERVINO trial data, where etentamig nearly doubled response rates and cut the risk of disease progression by 60% compared to standard therapies in heavily pretreated multiple myeloma patients.
AbbVie has submitted a biologics license application (BLA) to the FDA seeking approval of etentamig (ABBV-383) for adults with relapsed/refractory multiple myeloma — a blood cancer that often becomes resistant to multiple lines of treatment. The application is backed by the phase 3 CERVINO trial, which enrolled 393 patients who had already been exposed to three major drug classes (proteasome inhibitors, immunomodulatory agents, and anti-CD38 antibodies).
Etentamig is a BCMA x CD3 bispecific T-cell engager given once monthly. In CERVINO, it significantly outperformed investigator-chosen standard therapies on both primary endpoints — overall response rate and progression-free survival — with a manageable safety profile and the added convenience of potential outpatient administration.
By the Numbers:
Why it matters: Multiple myeloma remains incurable for most patients, and options thin out quickly after triple-class exposure. Etentamig's once-monthly dosing, strong efficacy data, and low rates of severe side effects could make it a meaningful new option — especially for older patients and those treated outside of academic centers.
