AbbVie Submits Biologics License Application (BLA) for Etentamig to U.S. FDA for Adults Living With Relapsed/Refractory Multiple Myeloma
Key Highlights
- ➤AbbVie (ABBV) submits U.S. FDA BLA for investigational etentamig in relapsed/refractory multiple myeloma
- ➤CERVINO response rate reached 74.0% versus 45.7% with standard available therapies
- ➤Etentamig delivered 60% progression-free survival risk reduction versus standard available therapies
- ➤Etentamig treatment discontinuations from adverse events were 3.6% versus 14%
- ➤Monthly dosing followed a single step-up dose in the Phase 3 study
Expert Statements
Daejin Abidoye, M.D., vice president and therapeutic area head, oncology, solid tumor and hematology, AbbVie
“Multiple myeloma is a chronic blood cancer that can reshape a person's life. Patients deserve therapeutic options that are not only effective, but also support the realities of when, where and how they receive treatment”
Daejin Abidoye, M.D., vice president and therapeutic area head, oncology, solid tumor and hematology, AbbVie
“This milestone brings us a step closer to potentially delivering a novel, patient-centered treatment option with a manageable safety profile and the convenience of a monthly dosing schedule that can help meet the needs of people living with multiple myeloma wherever they receive care.”
AbbVie Submits Biologics License Application (BLA) for Etentamig to U.S. FDA for Adults Living With Relapsed/Refractory Multiple Myeloma PR Newswire
– Etentamig is a second-generation BCMA-directed bispecific antibody T-cell engager with a clinical profile and dosing schedule that can potentially support treatment across a broad range of settings, including in community-based care – In the Phase 3 CERVINO study, etentamig achieved statistically significant improvements in overall response rate (ORR) and progression-free survival (PFS) versus investigator's choice of standard available therapies – Submission underscores AbbVie's ambition to advance a broad multiple myeloma portfolio that addresses disease complexity and supports patients' evolving care goals
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