Talquetamab

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Talquetamab
Monoclonal antibody
TypeBi-specific T-cell engager
SourceHumanized
TargetGPRC5D, CD3
Clinical data
Trade namesTalvey
Other namesTalquetamab-tgvs
AHFS/Drugs.comMonograph
MedlinePlusa623047
License data
Pregnancy
category
  • Contraindicated[1]
Routes of
administration		Subcutaneous
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG

Talquetamab, sold under the brand name Talvey, is a humanized monoclonal antibody used for the treatment of multiple myeloma.[1][4] It is a bispecific GPRC5D-directed CD3 T-cell engager.[1] Talquetamab is a bispecific antibody against two targets: human CD3, a T-cell surface antigen, and human G-protein coupled receptor family C group 5 member D (GPRC5D), a tumor-associated antigen with potential antineoplastic activity.[5] Talquetamab binds both targets, drawing the T cells close to the tumor cells, causing a cytotoxic T-lymphocyte response.[5] It is being developed by Janssen Pharmaceuticals.[6]

The most common adverse reactions include cytokine release syndrome, dysgeusia, nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, decreased weight, dry mouth, pyrexia, xerosis, dysphagia, upper respiratory tract infection, and diarrhea.[7]

Talquetamab was approved for medical use in both the United States[1][7][8] and the European Union[3] in August 2023. The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[9]

Medical uses

Talquetamab is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.[1][7][3][4]

Adverse effects

The US Food and Drug Administration (FDA) label prescribing information has a boxed warning for life-threatening or fatal cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity.[1][7]

History

Efficacy was evaluated in MMY1001 (MonumenTAL-1) (NCT03399799, NCT04634552), a single-arm, open-label, multicenter study that included 187 participants who had previously received at least four prior systemic therapies.[7] Participants received talquetamab-tgvs 0.4 mg/kg subcutaneously weekly, following two step-up doses in the first week of therapy, or talquetamab-tgvs 0.8 mg/kg subcutaneously biweekly (every two weeks), following three step-up doses, until disease progression or unacceptable toxicity.[7]

The main efficacy outcome measures were overall response rate and duration of response as assessed by an independent review committee using IMWG criteria.[7] The primary efficacy population consisted of participants who had previously received at least four prior lines of therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.[7] Overall response rate in the 100 participants receiving 0.4 mg/kg weekly was 73% (95% confidence interval (CI): 63.2%, 81.4%) and median duration of response was 9.5 months (95% CI: 6.5, not estimable).[7] Overall response rate in the 87 participants receiving 0.8 mg/kg biweekly was 73.6% (95% CI: 63%, 82.4%) and median duration of response was not estimable.[7] An estimated 85% of responders maintained response for at least nine months.[7]

The FDA granted the application for talquetamab priority review, breakthrough therapy, and orphan drug designations.[7]

Society and culture

Legal status

In the United States, Janssen received breakthrough therapy designation for talquetamab in June 2022, for the treatment of adults with relapsed or refractory multiple myeloma, who have previously received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody.[10] Janssen filed for approval from the FDA in December 2022,[11] and from the European Medicines Agency in January 2023.[12]

On 20 July 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion, recommending the granting of a conditional marketing authorization for the medicinal product Talvey, intended for the treatment of multiple myeloma.[13] Talvey was reviewed under EMA's accelerated assessment program.[13] The applicant for this medicinal product is Janssen-Cilag International N.V.[13] Talquetamab was approved for medical use in the European Union in August 2023.[3][4]

References

  1. ^ a b c d e f g "Talvey- talquetamab injection". DailyMed. U.S. National Library of Medicine. 18 August 2023. Archived from the original on 24 August 2023. Retrieved 23 August 2023.
  2. ^ "FDA-sourced list of all drugs with black box warnings (Use Download Full Results and View Query links.)". nctr-crs.fda.gov. FDA. Retrieved 22 October 2023.
  3. ^ a b c d "Talvey Product information". Union Register of medicinal products. 22 August 2023. Archived from the original on 25 August 2023. Retrieved 25 August 2023.
  4. ^ a b c d "Talvey EPAR". European Medicines Agency. 21 September 2023. Retrieved 6 October 2023.
  5. ^ a b "Talquetamab". NCI Drug Dictionary. National Cancer Institute. Archived from the original on 11 August 2023. Retrieved 30 January 2023.
  6. ^ Chari A, Minnema MC, Berdeja JG, Oriol A, van de Donk NW, Rodríguez-Otero P, et al. (December 2022). "Talquetamab, a T-Cell-Redirecting GPRC5D Bispecific Antibody for Multiple Myeloma". The New England Journal of Medicine. 387 (24): 2232–2244. doi:10.1056/NEJMoa2204591. PMID 36507686. S2CID 254560960.
  7. ^ a b c d e f g h i j k l "FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma". U.S. Food and Drug Administration (FDA). 9 August 2023. Archived from the original on 11 August 2023. Retrieved 10 August 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  8. ^ Theoret MR (2023). "Talvey (talquetamab-tgvs) injection" (PDF). Approval Letter. U.S. Food and Drug Administration. Archived from the original (PDF) on 11 August 2023. Public Domain This article incorporates text from this source, which is in the public domain.
  9. ^ New Drug Therapy Approvals 2023 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024.
  10. ^ "FDA Grants Breakthrough Therapy Designation to Talquetamab for R/R Myeloma". Targeted Oncology. 29 June 2022. Archived from the original on 11 August 2023. Retrieved 30 January 2023.
  11. ^ "Janssen Submits Biologics License Application to U.S. FDA for Talquetamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma". The Janssen Pharmaceutical Companies of Johnson & Johnson (Press release). 9 December 2022.
  12. ^ "Application to the European Medicines Agency Seeking Approval of Talquetamab for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma". Janssen Pharmaceutica NV (Press release). 3 January 2023.
  13. ^ a b c "Talvey: Pending EC decision". European Medicines Agency (EMA). 21 July 2023. Archived from the original on 25 August 2023. Retrieved 25 August 2023. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

External list

  • Clinical trial number NCT03399799 for "Dose Escalation Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma (MonumenTAL-1)" at ClinicalTrials.gov
  • Clinical trial number NCT04634552 for "A Study of Talquetamab in Participants With Relapsed or Refractory Multiple Myeloma" at ClinicalTrials.gov
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