Talvey FDA Approval History
Last updated by Judith Stewart, BPharm on Aug 11, 2023.
FDA Approved: Yes (First approved August 9, 2023)
Brand name: Talvey
Generic name: talquetamab-tgvs
Dosage form: Injection
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Multiple Myeloma
Talvey (talquetamab-tgvs) is a first-in-class, bispecific GPRC5D-directed CD3 T-cell engager for the treatment of patients with heavily pretreated multiple myeloma.
- Talvey (talquetamab-tgvs) 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. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). - Multiple myeloma is an incurable blood cancer that affects a type of white blood cell called plasma cells, which are found in the bone marrow.
- Talvey works in the treatment of myeloma targeting both G protein-coupled receptor class C group 5 member D (GPRC5D), a novel multiple myeloma target which is highly expressed on the surface of multiple myeloma cells, and CD3, a primary component of the T-cell receptor involved in activating T-cells. It is thought that the talquetamab-tgvs activated T-cells cause the release of proinflammatory cytokines, resulting in the lysis of multiple myeloma cells.
- Talvey is administered by subcutaneous injection either weekly or biweekly after an initial step-up phase.
- The Talvey product label carries a Boxed Warning for an increased risk of Cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). Talvey is only available only through a restricted program called the TECVAYLI® and TALVEY™ Risk Evaluation and Mitigation Strategy (REMS).
- Warnings and precautions associated with Talvey include oral toxicity and weight loss, infections, cytopenias, skin toxicity, hepatoxicity and embryo-fetal toxicity.
- The most common adverse reactions (≥20 percent) include pyrexia, CRS, dysgeusia, nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, weight decreased, dry mouth, xerosis, dysphagia, upper respiratory tract infection, diarrhea, hypotension and headache.
The most common Grade 3 or 4 laboratory abnormalities (≥30 percent) include decreased lymphocyte count, decreased neutrophil count, decreased white blood cells, and decreased hemoglobin.
Development timeline for Talvey
Further information
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