FDA Approves J&J’s sBLA for Use of its TECVAYLI® (teclistamab) in the Treatment of Relapsed or Refractory Multiple Myeloma

On 20 February 2024, FDA approved J&J ‘s supplemental biologics license application to use TECVAYLI® (teclistamab) with a reduced dosing frequency for cancer patients.  This approval increases dosing flexibility in patients on a weight-based dosing regimen.  TECVAYLI® was originally approved by the FDA in October 2022 for the treatment of adult patients with RRMM who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.