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

AbbVie has submitted a Biologics License Application (BLA) to the U.S. FDA for etentamig (ABBV-383), an investigational second-generation BCMA x CD3 bispecific antibody T-cell engager, for the treatment of adults with relapsed or refractory multiple myeloma. The submission is supported by positive data from the Phase 3 CERVINO trial, which demonstrated statistically significant improvements in overall response rate and progression-free survival compared to standard available therapies.