Tecvayli (teclistamab-cqyv) biweekly dosing approved by the FDA for the treatment of patients with relapsed or refractory multiple myeloma

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. Tecvayli has been prescribed to more than 3,600 patients in the U.S. since approval.

This approval is based on results from the Phase 1/II MajesTEC-1 study (Phase 1: NCT03145181; Phase II: NCT04557098). In the Phase 1/II MajesTEC-1 study, patients were initially treated with the recommended Phase II dose (RP2D) of 1.5 mg/kg Tecvayli weekly (QW) administered subcutaneously. Patients who achieved a confirmed CR or better for six months or longer (Phase II), were eligible to reduce dosing frequency to 1.5 mg/kg Q2W until disease progression or unacceptable toxicity.

“Tecvayli is the only BCMA-targeted immune-based therapy with weight-based dosing. This approval of biweekly dosing for eligible patients will further enable clinicians to meet the individual needs of patients who may want flexibility in their dosing schedules,” said Rachel Kobos, M.D., Vice President, Oncology Research & Development, Johnson & Johnson Innovative Medicine. “As the first bispecific approved for the treatment of multiple myeloma, combined with the longest in-market experience by physicians, Tecvayli is another example of our commitment to pioneering cutting-edge research to help improve outcomes for patients with multiple myeloma.”