AbbVie Submits FDA Biologics License Application for Etentamig in Multiple Myeloma
AbbVie (ABBV) has officially submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for etentamig. The application seeks approval for treating patients with relapsed or refractory multiple myeloma. The submission is supported by clinical data from the Phase 3 CERVINO study, which evaluated the efficacy of etentamig against an investigator's choice of standard available therapies. This regulatory milestone represents a significant step in AbbVie's efforts to expand its oncology portfolio and address unmet needs in hematologic malignancies.

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Topics: Biologics License Application Clinical Trials Multiple Myeloma