Posted by Michael Wonder on 29 Jun 2022
Janssen announces U.S. FDA breakthrough therapy designation granted for talquetamab for the treatment of relapsed or refractory multiple myeloma
29 June 2022 - Novel GPRC5DxCD3 bispecific antibody receives breakthrough therapy designation based upon results from the Phase 1/2 MonumenTAL-1 study.
Janssen announced today that the U.S. FDA has granted breakthrough therapy designation for talquetamab for the treatment of adult patients with relapsed or refractory multiple myeloma, who have previously received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.
