According to a February 20, 2023 press release from Johnson & Johnson, the U.S. FDA has "approved the supplemental Biologics License Application (sBLA) for TECVAYLI® (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks (Q2W) in patients with relapsed or refractory multiple myeloma (RRMM) who have achieved and maintained a complete response (CR) or better for a minimum of six months. There is a continued unmet need for patients with multiple myeloma and this approval allows increased flexibility in dosing schedule for appropriate patients with a weight-based regimen."

"Tecvayli, which is administered subcutaneously, was the first bispecific antibody targeting B-cell maturation antigen (BCMA) on multiple myeloma cells and CD3 on T-cells to activate an immune response. Tecvayli was approved 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. This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Tecvyali has been prescribed to more than 3,600 patients in the U.S. since approval." Read the full press release to learn more.



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