Johnson & Johnson Receives FDA Approval for Talvey in Relapsed or Refractory Multiple Myeloma

Johnson & Johnson today announced that the FDA has granted accelerated approval to Talvey (talquetamab-tgvs) for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. Talvey is a first-in-class bispecific antibody targeting GPRC5D on myeloma cells and CD3 on T cells. In the MonumenTAL-1 trial, Talvey demonstrated an overall response rate of 73% in patients receiving the 0.8 mg/kg weekly dose. The approval of Talvey provides a new treatment option for patients with heavily pretreated multiple myeloma. J&J continues to study Talvey in earlier lines of therapy and in combination regimens.