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FDA approved Talvey (talquetamab) for Relapsed/Refractory Multiple MyelomaFDA approved new multiple myeloma drug Talvey for certain patients.

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Key Takeaway
Consider Talvey for heavily pretreated multiple myeloma patients; monitor for CRS and neurologic toxicity.

The FDA has granted accelerated approval to Talvey (talquetamab) 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. Talvey is a bispecific GPRC5D-directed CD3 T-cell engager administered subcutaneously. The approval is based on response rate and durability of response; continued approval may depend on verification of clinical benefit in confirmatory trials. Clinicians should note that patients require hospitalization for 48 hours after all doses within the step-up dosing schedule due to risks of cytokine release syndrome and neurologic toxicity.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

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.

Indication & Patient Population

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.

Dosing & Administration

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.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

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.

Place in Therapy

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.

The U.S. Food and Drug Administration has approved a new drug called Talvey (talquetamab) for adults with multiple myeloma, a type of blood cancer. This drug is for patients whose cancer has returned or stopped responding after at least four prior treatments. Those treatments must have included a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Talvey is a type of immunotherapy known as a bispecific T-cell engager. It works by helping the body's immune cells attack the cancer. The drug is given as an injection under the skin. The approval is based on how many patients responded to the drug and how long that response lasted. However, the FDA may require more studies to confirm the drug's benefit.

Because Talvey can cause serious side effects like cytokine release syndrome and neurologic problems, patients must stay in the hospital for 48 hours after each dose during the first few weeks of treatment. This is a standard safety measure.

If you or a loved one has multiple myeloma, this new approval offers another treatment option. But it is important to talk to your doctor about whether Talvey is right for you. Your doctor can explain the risks and benefits based on your specific health situation.

What this means for you:
Talvey is a new option for certain multiple myeloma patients, but talk to your doctor about risks and benefits.

Study Details

Study typeFda approval
PublishedAug 2023
View Original Abstract ↓
1 INDICATIONS AND USAGE 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 [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). TALVEY is a 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). ( 1 )
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