Tarlatamab

Last updated

Tarlatamab
Monoclonal antibody
Type Bi-specific T-cell engager
Source Human
Target DLL3 and CD3
Clinical data
Trade names Imdelltra
Other namesAMG757; AMG-757, tarlatamab-dlle
AHFS/Drugs.com Monograph
MedlinePlus a624037
License data
Routes of
administration 		Intravenous
Drug class Antineoplastic
ATC code
Legal status
Legal status
Identifiers
CAS Number
DrugBank
UNII
KEGG
Chemical and physical data
Formula C4664H7139N1259O1454S34
Molar mass 105202.82 g·mol−1

Tarlatamab, sold under the brand name Imdelltra, is an anti-cancer medication used for the treatment of extensive-stage small cell lung cancer. [5] It is a bispecific T-cell engager that binds delta-like ligand 3 and CD3. [5]

Contents

The most common adverse reactions include cytokine release syndrome, fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, and constipation, anemia and nausea. [6]

Tarlatamab was approved for medical use in the United States in May 2024. [6] [7] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication. [8]

Medical uses

Tarlatamab is indicated for the treatment of adults with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. [5] [6]

Adverse effects

The prescribing information for tarlatamab includes a boxed warning for life-threatening or fatal cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome, as well as warnings and precautions for cytopenias, infections, hepatotoxicity, hypersensitivity, and embryo-fetal toxicity. [9]

The most common adverse reactions include cytokine release syndrome, fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, and constipation, anemia and nausea. [6] The most common grade 3 or 4 laboratory abnormalities include decreased lymphocytes, decreased sodium, increased uric acid, decreased total neutrophils, decreased hemoglobin, increased activated partial thromboplastin time, and decreased potassium. [6]

History

Efficacy was evaluated in 99 participants with relapsed/refractory extensive stage small cell lung cancer with disease progression following platinum-based chemotherapy enrolled in DeLLphi-301 [NCT05060016], an open-label, multicenter, multi-cohort study. [6] Participants with symptomatic brain metastases, interstitial lung disease or non-infectious pneumonitis, and active immunodeficiency were excluded. [6] Participants received tarlatamab until disease progression or unacceptable toxicity. [6]

The US Food and Drug Administration (FDA) granted the application for tarlatamab priority review, breakthrough therapy, and orphan drug designations. [6]

Efficacy was evaluated in DeLLphi-304 (NCT05740566), a multi-center, randomized, open-label trial in people with small cell lung cancer with disease progression following treatment with platinum-based chemotherapy with or without an anti-PD-(L)1 antibody. [9] In DeLLphi-304, 509 participants were randomized (1:1) to receive either tarlatamab-dlle or the investigator's choice of standard of care chemotherapy (topotecan, lurbinectedin, or amrubicin) until disease progression or unacceptable toxicity. [9]

In November 2025, the FDA granted traditional approval to tarlatamab for adults with extensive stage small cell lung cancer with disease progression on or after platinum-based chemotherapy. [9] Tarlatamab received accelerated approval for this indication in 2024. [9]

Society and culture

Tarlatamab was approved for medical use in the United States in May 2024. [6] [7] [10] [11]

Names

Tarlatamab is the international nonproprietary name [12] and the United States Adopted Name. [13]

Tarlatamab is sold under the brand name Imdelltra. [6]

References

  1. ↑ "Summary Basis of Decision for Imdelltra". Drug and Health Products Portal. 11 February 2025. Retrieved 22 June 2025.
  2. ↑ "Notice: Multiple additions to the Prescription Drug List (PDL) [2024-12-20]". Health Canada . 20 December 2024. Retrieved 21 December 2024.
  3. ↑ "Imdelltra product information". Health Canada . 11 October 2024. Retrieved 27 December 2024.
  4. ↑ "Regulatory Decision Summary for Imdelltra". Drug and Health Products Portal. 11 September 2024. Retrieved 27 December 2024.
  5. 1 2 3 4 "Imdelltra (AMG757)- tarlatamab-dlle kit". DailyMed. 16 May 2024. Retrieved 31 May 2024.
  6. 1 2 3 4 5 6 7 8 9 10 11 "FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer". U.S. Food and Drug Administration (FDA). 16 May 2024. Retrieved 17 May 2024.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  7. 1 2 "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Archived from the original on 19 April 2024. Retrieved 29 November 2024.
  8. ↑ New Drug Therapy Approvals 2024 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2025. Archived from the original on 21 January 2025. Retrieved 21 January 2025.
  9. 1 2 3 4 5 "FDA grants traditional approval to tarlatamab-dlle for extensive stage small cell lung cancer". U.S. Food and Drug Administration (FDA). 19 November 2025. Retrieved 21 November 2025.PD-icon.svg This article incorporates text from this source, which is in the public domain .
  10. ↑ "Cancer Accelerated Approvals". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 6 December 2024.
  11. ↑ "FDA approves Imdelltra (tarlatamab-dlle), the first and only T-cell engager therapy for the treatment of extensive-stage small cell lung cancer" (Press release). Amgen. 16 May 2024. Retrieved 18 May 2024– via PR Newswire.
  12. ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85". WHO Drug Information. 35 (1). 2021. hdl: 10665/340684 .
  13. ↑ "Tarlatamab". AMA Finder. Retrieved 18 May 2024.

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