HORSHAM, PA. — Johnson & Johnson announced today that the U.S. Food and Drug Administration (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. 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 1/2 MajesTEC-1 study (Phase 1: NCT03145181; Phase 2: NCT04557098). In the Phase 1/2 MajesTEC-1 study, patients were initially treated with the recommended Phase 2 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 2), 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. Today’s 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.”
About the MajesTEC-1 Study
MajesTEC-1 (NCT03145181, NCT04557098), is a Phase 1/2 single-arm, open-label, multicohort, multicenter dose-escalation study to evaluate the safety and efficacy of teclistamab in adults with RRMM who received three or more prior lines of therapy (n=165).
Phase 1 of the study (NCT03145181) was conducted in two parts: dose escalation (Part 1) and dose expansion (Part 2). It evaluated safety, tolerability, pharmacokinetics, and preliminary efficacy of teclistamab in adult participants with RRMM. Phase 2 of the study (NCT04557098) evaluated the efficacy of teclistamab at the RP2D, established at subcutaneous 1.5 mg/kg weekly, as measured by ORR.
About Johnson & Johnson
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