Tarlatamab
| 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 | Multum Consumer Information |
| 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.[1] It is a bispecific T-cell engager that binds delta-like ligand 3 and CD3.[1]
The most common adverse reactions include cytokine release syndrome, fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, and constipation, anemia and nausea.[2]
Tarlatamab was approved for medical use in the United States in May 2024.[2][3]
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.[1][2]
Adverse effects
The prescribing information for tarlatamab includes a boxed warning for serious or life-threatening cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS).[1]
The most common adverse reactions include cytokine release syndrome, fatigue, pyrexia, dysgeusia, decreased appetite, musculoskeletal pain, and constipation, anemia and nausea.[2] 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.[2]
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.[2] Participants with symptomatic brain metastases, interstitial lung disease or non-infectious pneumonitis, and active immunodeficiency were excluded.[2] Participants received tarlatamab until disease progression or unacceptable toxicity.[2]
The FDA granted the application for tarlatamab priority review, breakthrough therapy, and orphan drug designations.[2]
Society and culture
Legal status
Tarlatamab was approved for medical use in the United States in May 2024.[2][3][4][5]
Names
Tarlatamab is the international nonproprietary name[6] and the United States Adopted Name.[7]
References
- ^ a b c d e "Imdelltra (AMG757)- tarlatamab-dlle kit". DailyMed. 16 May 2024. Retrieved 31 May 2024.
- ^ a b c d e f g h i j "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.
This article incorporates text from this source, which is in the public domain.
- ^ a b "Novel Drug Approvals for 2024". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 29 November 2024.
- ^ "Cancer Accelerated Approvals". U.S. Food and Drug Administration (FDA). 1 October 2024. Retrieved 6 December 2024.
- ^ "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.
- ^ World Health Organization (2021). "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85". WHO Drug Information. 35 (1). hdl:10665/340684.
- ^ "Tarlatamab". AMA Finder. Retrieved 18 May 2024.
Further reading
- Ahn MJ, Cho BC, Felip E, Korantzis I, Ohashi K, Majem M, et al. (October 2023). "Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer". The New England Journal of Medicine. 389 (22): 2063–2075. doi:10.1056/NEJMoa2307980. PMID 37861218.
- Paz-Ares L, Champiat S, Lai WV, Izumi H, Govindan R, Boyer M, et al. (June 2023). "Tarlatamab, a First-in-Class DLL3-Targeted Bispecific T-Cell Engager, in Recurrent Small-Cell Lung Cancer: An Open-Label, Phase I Study". Journal of Clinical Oncology. 41 (16): 2893–2903. doi:10.1200/JCO.22.02823. PMC 10414718. PMID 36689692.
External links
- "Tarlatamab". NCI Drug Dictionary.
- "Tarlatamab (Code C175858)". NCI Thesaurus.
- Clinical trial number NCT05060016 for "A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC) (DeLLphi-301)" at ClinicalTrials.gov
