AbbVie has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for etentamig, a second-generation BCMA x CD3 bispecific antibody T-cell engager administered intravenously for the treatment of adults with Relapsed or Refractory Multiple Myeloma (RRMM).

BCMA-directed bispecific antibodies and CAR-T therapies have significantly changed the treatment landscape for people living with multiple myeloma. However, their broader adoption may be limited by Adverse Events (AEs) such as cytokine release syndrome, infections or neurotoxicity, as well as specialised administration and monitoring requirements.

Additionally, as disease relapses, treatment options in later lines of therapy become increasingly limited. Together, these factors highlight the need for additional therapies that may address the biology of the disease and help support effective treatment delivery across diverse care environments.

Daejin Abidoye, MD, Vice President and Therapeutic Area Head—Oncology, Solid Tumor and Hematology, AbbVie, said, "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. 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."

The submission is supported by results from the global, phase 3, multicenter, randomised CERVINO study evaluating etentamig versus investigator's choice of Standard Available Therapies (SAT) in patients with triple-class exposed RRMM who had received at least 2 prior lines of therapy.

Topline results were announced earlier this year.