FDA Approves Talvey for Multiple Myeloma on August 9, 2023

Jul 22, 2024

What is Talvey prescribed for?  

Talvey is prescribed to treat adults with relapsed or refractory multiple myeloma who have received at least four prior therapies.

What is the name of the drug and what does it do?

The name of the drug is Talvey, pronounced tal vay, (generic name: talquetamab-tgvs). It is a prescription medication approved to treat adults with relapsed or refractory multiple myeloma who have tried at least four other therapies.

 Talvey targets and kills cancerous cells in the bone marrow.

How does it work?

Talvey is a type of cancer treatment designed to target and destroy myeloma cells, which are a type of cancer cell found in bone marrow. It works using a dual-targeting approach. 

The drug has two parts: one part attaches to a protein called GPRC5D found only on the surface of myeloma cells, and the other part attaches to a protein called CD3, which is found on T-cells. 

T-cells are a type of immune cell that can kill cancer cells.

By binding to both these proteins, Talvey acts like a bridge, pulling the T-cells directly next to the myeloma cells. This close proximity triggers the T-cells to activate and attack, leading to the destruction of the myeloma cells. 

This method helps to direct the body’s immune response specifically against the cancer cells, potentially reducing the impact on healthy cells and improving the effectiveness of the treatment.

What did the research discover?

Clinical trials evaluated the safety and effectiveness of Talvey in patients with relapsed or refractory multiple myeloma who had undergone at least four prior therapies.

 The trials demonstrated that Talvey significantly reduced tumor size and, in some cases, led to complete remission. 

The study included patients who had very limited treatment options left and had not responded to other available treatments.

These promising results led to the FDA’s approval of Talvey, providing a new treatment option for patients who have exhausted other therapies. 

What are some of the side effects?

The side effects listed are from the product manufacturer. As health scientists, we share this information to keep you informed without causing undue worry. Many side effects diminish over time, and not all patients experience them. If prescribed medication, take it as directed and consult your healthcare professional if you have any concerning side effects.

  • Cytokine release syndrome (CRS)( A severe immune reaction that can cause fever, low blood pressure, and difficulty breathing)
  • Neurologic toxicity(confusion, difficulty speaking, and seizures)
  • Dry Mouth
  • Weight Loss
  • Cytopenias(Low levels of blood cells, such as neutrophils and platelets)
  • Skin toxicity(Reactions including rash and other skin disorders)
  • Hepatotoxicity(Elevated liver enzymes indicating potential liver damage)

What are the dosage recommendations and how is it prescribed?

Talvey is given as an injection under the skin. The recommended schedule involves gradually increasing doses to lower the risk of serious side effects like CRS.

  • Day 1: Step-up dose of 0.01 mg/kg
  • Day 4: Step-up dose of 0.06 mg/kg
  • Day 7: First treatment dose of 0.4 mg/kg

After the initial step-up phase, Talvey can be given weekly (0.4 mg/kg) or every two weeks (0.8 mg/kg), depending on how the patient responds and tolerates the treatment.

Hospitalization for 48 hours is recommended after each step-up dose to monitor for severe reactions.

Source:

Highlights of Prescribing Information for Talvey. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761342s000lbl.pdf. Accessed 16 July 2024.

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