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.

About TALVEY™

TALVEY™ is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T cells and GPRC5D expressed on the surface of multiple myeloma cells and non-malignant plasma cells, as well as healthy tissues such as epithelial cells in keratinized tissues of the skin and tongue.

In vitro, TALVEY activated T cells caused the release of proinflammatory cytokines and resulted in the lysis of multiple myeloma cells. TALVEY™ had anti-tumor activity in mouse models of multiple myeloma.

For subcutaneous injection.

Administer pretreatment medications prior to each dose of TALVEY™ in the step-up dosing schedule as recommended [see Dosage and Administration (2.2, 2.3) in the full Prescribing Information].

Administer TALVEY™ subcutaneously according to the step-up dosing schedule in Table 1 and Table 2 in the full Prescribing Information to reduce the incidence and severity of CRS [see Dosage and Administration (2.2) in the full Prescribing Information].

TALVEY™ should only be administered by a qualified healthcare professional with appropriate medical support to manage severe reactions such as CRS and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome (ICANS) [see Warnings and Precautions (5.1, 5.2) in the full Prescribing Information].

Administer TALVEY™ subcutaneously on a weekly or biweekly (every 2 weeks) dosing schedule according to Table 1 or Table 2 in the full Prescribing Information. Continue treatment until disease progression or unacceptable toxicity.

Due to the risk of CRS and neurologic toxicity, including ICANS, patients should be hospitalized for 48 hours after administration of all doses within the TALVEY™ step-up dosing schedule [see Dosage and Administration (2.5) and Warnings and Precautions (5.1, 5.2) in the full Prescribing Information].


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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.