AbbVie Submits Biologics License Application (BLA) for Etentamig to U.S. FDA for Adults Living With Relapsed/Refractory Multiple Myeloma
AbbVie submitted a Biologics License Application to the FDA for etentamig, a second-generation BCMA x CD3 bispecific antibody, for adults with relapsed/refractory multiple myeloma. The submission is supported by the Phase 3 CERVINO study (393 patients), where etentamig achieved a 74.0% overall response rate versus 45.7% for standard available therapies and a 60% reduction in progression-free survival risk. Safety was differentiated, with low TEAE-related discontinuations (3.6% vs 14%) and only grade 1-2 cytokine release syndrome among single step-up dose patients, supporting convenient monthly dosing.
Key figures
- Drug Name
- etentamig (ABBV-383)
- Phase Of Trial
- Phase 3
- Orr sat
- 45.7%
- Orr etentamig
- 74.0%
- Grade5 infections
- 1.5% vs 3.1% (etentamig vs SAT)
- Pfs risk reduction
- 60%
- Patients randomized
- 393
- Discontinuation teae
- 3.6% vs 14% (etentamig vs SAT)
- Crs incidence single stepup
- 28.3%
AI analysis
The rest of the AI analysis, red flags and sentiment are part of Signal8 Pro.
AI-generated analysis of a public disclosure. Not investment advice; verify against the original document.