TALVEY™ (talquetamab-tgvs) FDA Approved for Super Refractory Multiple Myeloma

TALVEY™ (talquetamab-tgvs) is a newly approved drug indicated for the treatment of highly refractory multiple myeloma [Ref]. 

It is indicated for the treatment of multiple myeloma in adult patients who have relapsed or those who are refractory to at least 4 first line of treatment, including:

  • Proteasome Inhibitor (Bortezomib)
  • An Immunomodulatory agent (thalidomide, lenalidomide, and pomalidomide), and 
  • Anti-CD 38 antibody (Daratumumab, Isatuximab, and Elotuzumab)

Talquetamab targets 2 receptors: CD-3 positive T cells and GPRC5D (G protein-coupled receptor, family C, group 5, member D).

GPRC5D is specifically expressed in the plasma cells of patients with multiple myeloma.

In a clinical trial, the response rate documented with Talvey at different doses was significant compared to other FDA-approved medications.

The table below summarizes the response rate of Talvey in comparison with other drugs [Ref]:


Response Rate (%)

Talquetamab 405-μg dose


Talquetamab 800-μg dose


Selinexor + Dexamethasone


Belantamab Mafodotin


Idecabtagene Vicleucel


Ciltacabtagene Autoleuce


Contraindications, Precautions, and Side Effects of Talvey (Talquetamab):

Like most potent biological medicines and drugs targeting specific immune cells, Talvey (Talquetamab) is associated with significant side effects including:

  • Cytokine Release Syndrome (CRS). Symptoms of CRS include:
    • Fever and chills

    • Fatigue

    • Headache

    • Nausea and Vomiting

    • Muscle and joint pain

    • Tachycardia

    • Hypotension

    • Difficulty breathing

    • Swelling

    • Skin rash

    • Confusion or delirium

    • Seizures

    • Organ dysfunction (such as liver or kidney impairment)

    • Capillary leak syndrome (fluid leakage from blood vessels)

  • Neurotoxicity including ICANS (Immune Effector Cell-Associated Neurotoxicity Syndrome)
  • Oral toxicity manifests as altered taste, dry mouth, dysphagia, difficulty swallowing, and stomatitis.
  • Weight loss
  • Infections including serious infections such as fungal and serious bacterial and viral infections (COVID pneumonia)
  • Bone marrow suppression manifesting as low platelet counts, anemia, and neutropenia.
  • Skin toxicity may manifest as a rash or may be severe and manifest as Steven-Johnson syndrome.
  • Liver toxicity manifesting as raised liver functions and jaundice.