JNJ 64007957 filed with EMA for multiple myeloma.
Teclistamab is an investigational, off-the-shelf, T-cell redirecting, bispecific antibody targeting both B-cell maturation antigen (BCMA) and CD3.
The submission to the EMA is supported by data from MajesTEC-1 (NCT03145181, NCT04557098), an open-label, multicentre clinical trial evaluating the safety and efficacy of teclistamab in adults with RRMM. Efficacy outcomes assessed included overall response rate, very good partial response and complete response, using the International Myeloma Working Group (IMWG) criteria. Safety outcomes evaluated included dose limiting toxicity and the number of participants with adverse events as a measure of safety and tolerability. Updated MajesTEC-1 data were recently presented at the American Society of Hematology 2021 annual meeting.
The application to the EMA follows a Biologics License Application submitted to the FDA seeking approval of teclistamab for the treatment of RRMM. Additionally, a MAA for teclistamab was recently submitted to the Swiss Agency for Therapeutic Products (Swissmedic) through a Type A Project Orbis submission.
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