SignalFDA/Bio
AbbVie Submits Biologics License Application (BLA) for Etentamig to U.S. FDA for Adults Living With Relapsed/Refractory Multiple Myeloma
AbbVie's BLA submission to FDA for etentamig in relapsed/refractory multiple myeloma signals a regulatory catalyst.
Context
What happened: AbbVie submitted a Biologics License Application to the U.S. FDA for etentamig, an investigational BCMA x CD3 bispecific antibody T-cell engager given intravenously, for adults with relapsed or refractory multiple myeloma.
Key numbers: Phase 3 CERVINO: ORR 74.0% vs 45.7% and 60% risk reduction in PFS versus standard therapies.
Why it matters: AbbVie says the submission supports its aim to advance a broad multiple myeloma portfolio, and the company describes monthly dosing as potentially supporting treatment across settings including community-based care.
Source: eodhd
Market: +0.4% today ($286.74), +27.1% YTD, 0.9x vol — as of 13:15 UTC
Verified: Q3_2026 (Oct 30) revenue $17.3B vs $17.3B est; next print ~Jan 29
What changed
AbbVie submitted a Biologics License Application to the U.S. FDA for etentamig, an investigational BCMA x CD3 bispecific antibody T-cell engager given intravenously, for adults with relapsed or refractory multiple myeloma.
Why it matters
AbbVie says the submission supports its aim to advance a broad multiple myeloma portfolio, and the company describes monthly dosing as potentially supporting treatment across settings including community-based care.
Source: eodhd
Market: +0.4% today ($286.74), +27.1% YTD, 0.9x vol — as of 13:15 UTC
Verified: Q3_2026 (Oct 30) revenue $17.3B vs $17.3B est; next print ~Jan 29