Reduced Tecvayli dosing approved by FDA

The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Tecvayli (teclistamab-cqyv) for a reduced dosing frequency of 1.5mg/kg every two weeks in relapsed or refractory multiple myeloma (RRMM) patients who have achieved and maintained a complete response or better for a minimum of six months.

Johnson & Johnson (NYSE: JNJ) initially won approval for the product 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.

Tecvayli, which is administered subcutaneously, was the first bispecific antibody targeting B-cell maturation antigen on multiple myeloma cells and CD3 on T-cells to activate an immune response.