FDA Approves Talvey (talquetamab) for Relapsed/Refractory Multiple Myeloma

Talvey is a bispecific GPRC5D-directed CD3 T-cell engager. It binds to GPRC5D on multiple myeloma cells and CD3 on T-cells, activating T-cells to kill tumor cells.

Talvey is 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.

Talvey is administered subcutaneously. Two dosing schedules are available: weekly and biweekly. The weekly schedule includes step-up doses of 0.01 mg/kg on Day 1, 0.06 mg/kg on Day 4, and a first treatment dose of 0.4 mg/kg on Day 7, followed by 0.4 mg/kg once weekly. The biweekly schedule includes step-up doses of 0.01 mg/kg on Day 1, 0.06 mg/kg on Day 4, 0.4 mg/kg on Day 7, a first treatment dose of 0.8 mg/kg on Day 10, followed by 0.8 mg/kg every 2 weeks. Patients should be hospitalized for 48 hours after all doses within the step-up dosing schedule. Pretreatment medications (corticosteroid, antihistamine, antipyretic) should be administered 1 to 3 hours before each step-up dose.

Trial data not available in label.

Warnings include cytokine release syndrome (CRS) and neurologic toxicity including immune effector cell-associated neurotoxicity syndrome (ICANS). Patients should be hospitalized for 48 hours after step-up doses. Talvey should only be administered by qualified healthcare professionals with appropriate medical support.

Talvey is a treatment option for heavily pretreated relapsed/refractory multiple myeloma patients who have received at least four prior lines of therapy, including a proteasome inhibitor, immunomodulatory agent, and anti-CD38 monoclonal antibody. It is approved under accelerated approval based on response rate and durability of response.