On February 20, the U.S. Food and Drug Administration (FDA) approved the supplemental biologics license application for teclistamab-cqyv (Tecvayli) for a reduced dosing frequency of 1.5 mg/kg every 2 weeks in patients with relapsed or refractory multiple myeloma who have achieved and maintained a complete response or better for a minimum of 6 months. This approval allows increased flexibility in dosing schedule for appropriate patients with a weight-based regimen.
Teclistamab, 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. The agent was approved by the FDA in October 2022 for the treatment of adult patients with relapsed or refractory multiple myeloma 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. Teclistamab has been prescribed to more than 3,600 patients in the U.S. since approval
This approval is based on results from the phase I/II MajesTEC-1 study (phase I ClinicalTrials.gov identifier NCT03145181; phase II NCT04557098). In MajesTEC-1, patients were initially treated with the recommended phase II dose of 1.5 mg/kg of teclistamab weekly, administered subcutaneously. Patients who achieved a confirmed complete response or better for 6 months or longer (phase II) were eligible to reduce dosing frequency to 1.5 mg/kg every 2 weeks until disease progression or unacceptable toxicity; results from this phase were reported by Usmani et al at the 2023 ASCO Annual Meeting (Abstract 293).
“[Teclistamab] is the only BCMA-targeted immune-based therapy with weight-based dosing. [The] 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, MD, Vice President, Oncology Research & Development, Johnson & Johnson Innovative Medicine, in a statement on the approval.
