AbbVie Submits Biologics License Application to FDA for Etentamig in Relapsed/Refractory Multiple Myeloma

AbbVie has announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for etentamig. This second-generation BCMA x CD3 bispecific antibody T-cell engager is proposed for the treatment of adults with relapsed or refractory multiple myeloma. The submission follows positive results from the Phase 3 CERVINO study, where etentamig demonstrated statistically significant improvements in overall response rate and progression-free survival compared to standard therapies.