TALVEY™ is a first-in-class bispecific GPRC5D-directed CD3 T-cell engager indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
Read the full Prescribing Information here, including Boxed WARNING.
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Reference: 1. TALVEY™ [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.
CD, cluster of differentiation; CRS, cytokine release syndrome; GPRC5D, G-protein coupled receptor family C group 5 member D; ICANS, immune effector cell-associated neurotoxicity syndrome.