The Janssen Pharmaceutical Companies of Johnson & Johnson (NYSE:JNJ) announced that the European Commission (EC) approved a Type II variation application for Tecvayli (teclistamab).
The approval provides the option for a reduced dosing frequency of 1.5mg/kg every two weeks in patients who have achieved a complete response (CR) or better for a minimum of six months.
Teclistamab was the first bispecific antibody targeting B-cell maturation antigen (BCMA) on multiple myeloma cells and CD3 on T-cells to receive approval in Europe for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three prior therapies.
The European approval was supported by positive results from the Phase 1/2 MajesTEC-1 study evaluating the safety and efficacy of teclistamab in patients with RRMM.
In October 2022, the FDA approved Tecvayli (teclistamab-cqyv) for relapsed or refractory multiple myeloma for patients who previously received four or more 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 a confirmatory trial(s).
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