Tuesday, the FDA approved Johnson & Johnson’s JNJ supplemental Biologics License Application 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.
Multiple myeloma is a type of blood cancer that affects types of white blood cells called plasma cells found in bone marrow.
The approval is based on results from the Phase 1/2 MajesTEC-1 study. Patients who achieved a confirmed CR or better for six months or longer (Phase 2) were eligible to reduce dosing frequency to 1.5 mg/kg Q2W until disease progression or unacceptable toxicity occurred.
Tecvayli, 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 adult patients with RRMM who received at least four prior lines of therapy.
This indication is approved under accelerated approval based on the 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.
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