U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for teclistamab in the treatment of relapsed or refractory multiple myeloma. This follows a PRIME (PRIority MEdicines) designation from the European Medicines Agency (EMA) received earlier this year. 

The Breakthrough and PRIME designations are supported by data from the Phase 1 MajesTEC-1 study, an open-label, multicenter clinical trial evaluating the safety and efficacy of teclistamab in adults with measurable multiple myeloma that is relapsed or refractory to established therapies or be intolerant of those established multiple myeloma therapies.

Multiple Myeloma that has relapsed and has become refractory to treatment, represents a patient population with unmet needs. Teclistamab is a bispecific IgG4 antibody that binds BCMA and CD3 to redirect T cells to multiple myeloma cells. According to the investigators, the current study is—to their knowledge—the first report of a T-cell–redirecting bispecific antibody for the treatment of patients with cancer.

The Myeloma panel of Gary Petersen, Jack Aiello, and Cynthia Chmielewski takes a deep dive on Teclistamab with Dr. Alfred L. Garfall hematologist oncologist from University of Pennsylvania.