FDA Brief: Teclistamab Receives Breakthrough Therapy Designation for Resistant Myeloma
Posted: Friday, June 25, 2021
The U.S. Food and Drug Administration (FDA) recently granted teclistamab Breakthrough Therapy designation for the treatment of relapsed or refractory multiple myeloma. The FDA’s designation comes after the European Medicines Agency granted teclistamab PRIME designation earlier this year. Teclistamab is an off-the-shelf, T-cell–redirecting, bispecific antibody targeting both B-cell maturation antigen and CD3 receptors.
The FDA’s decision is based on the data from the open-label, multicenter phase I MajesTEC-1 study (ClinicalTrials.gov identifier NCT03145181). The clinical trial investigated the safety and efficacy of teclistamab in adults with measurable multiple myeloma that is relapsed, refractory, or intolerant of current therapies. Updated results from the MajesTEC-1 study were presented during the 2021 American Society of Clinical Oncology Annual Meeting (Abstract 8007).
