First Bispecific Antibody, Teclistamab, Now FDA Approved in Multiple Myeloma

Today the FDA approved teclistamab, the first bispecific antibody to be used in relapsed or refractory multiple myeloma. 

Teclistamab (brand named TECVAYLI™) was approved for patients who received four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody. 

Teclistamab is an off-the-shelf product given by subcutaneous injection (a shot) that links BCMA, a target on myeloma cells, with T cells to kill myeloma. The drug was approved based on results from the Phase II MajesTEC-1 clinical trial that included 110 patients.

The trial data included the following results for patients who had a median of 5 prior lines of therapy (78% of patients received four or more prior lines of therapy): 

• 61.8% Overall Response Rate
• 58.8% of patietns had a very good partial response (VGPR) or better
• 28.2% achieved a complete response or better
• Median duration of response was 18.4 months

Click here to review the initial results of the Phase I/II study published in the New England Journal of Medicine.

We look forward seeing this new BCMA-directed therapy used in the myeloma clinic that can be used by patients who many not be able to wait for CAR T therapy. 

Additional Stories on Teclistamab

Updated Teclistamab Results in Multiple Myeloma

European Approval of Teclistamab Beats FDA to the Punch in Myeloma

ASCO 2021: FDA Grants Breakthrough Therapy Designation to Teclistamab in Mulitple Myeloma

FDA Expanded Access Program for Teclistamab

Guest Lecture: Teclistamab, Hans Lee, MD, MD Anderson Cancer Center

Myeloma Therapies: Bispecific Antibodies, CAR T and Antibody Drug Conjugates. How Do You Choose?