Johnson & Johnson Receives FDA Regular Approval for Tecvayli in Multiple Myeloma

Johnson & Johnson today announced that the FDA has granted regular approval to Tecvayli (teclistamab-cqyv) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. This regular approval converts the prior accelerated approval of Tecvayli and is based on updated data from the MajesTEC-1 trial showing durable responses. The updated data showed an overall response rate of 63% with a median duration of response of 18.4 months. These results confirm the durable clinical benefit of Tecvayli in heavily pretreated multiple myeloma.