Tarlatamab
Monoclonal antibody
From Wikipedia, the free encyclopedia
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]
| Monoclonal antibody | |
|---|---|
| Type | Bi-specific T-cell engager |
| Source | Human |
| Target | DLL3 and CD3 |
| Clinical data | |
| Trade names | Imdelltra |
| Other names | AMG757; 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 |
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
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
Legal status
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]
