Chemistry:Tarlatamab
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] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[4]
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 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.[5]
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 US Food and Drug Administration (FDA) granted the application for tarlatamab priority review, breakthrough therapy, and orphan drug designations.[2]
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.[5] 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.[5]
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.[5] Tarlatamab received accelerated approval for this indication in 2024.[5]
Society and culture
Legal status
Tarlatamab was approved for medical use in the United States in May 2024.[2][3][6][7]
Names
Tarlatamab is the international nonproprietary name[8] and the United States Adopted Name.[9]
Tarlatamab is sold under the brand name Imdelltra.[2]
References
- ↑ 1.0 1.1 1.2 "Imdelltra (AMG757)- tarlatamab-dlle kit". 16 May 2024. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e7b6163-5d83-42ea-82c9-cf7620cdc782.
- ↑ 2.00 2.01 2.02 2.03 2.04 2.05 2.06 2.07 2.08 2.09 2.10 "FDA grants accelerated approval to tarlatamab-dlle for extensive stage small cell lung cancer". 16 May 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer.
This article incorporates text from this source, which is in the public domain.
- ↑ 3.0 3.1 "Novel Drug Approvals for 2024". 1 October 2024. https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2024.
- ↑ (PDF) New Drug Therapy Approvals 2024 (Report). January 2025. https://www.fda.gov/media/184967/download. Retrieved 21 January 2025.
- ↑ 5.0 5.1 5.2 5.3 5.4 "FDA grants traditional approval to tarlatamab-dlle for extensive stage small cell lung cancer". 19 November 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer. This article incorporates text from this source, which is in the public domain.
- ↑ "Cancer Accelerated Approvals". 1 October 2024. https://www.fda.gov/drugs/resources-information-approved-drugs/ongoing-cancer-accelerated-approvals.
- ↑ "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.
- ↑ "International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85". WHO Drug Information 35 (1). 2021.
- ↑ "Tarlatamab". https://searchusan.ama-assn.org/finder/usan/search/JK-173/relevant/1/.
Further reading
- "Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer". The New England Journal of Medicine 389 (22): 2063–2075. October 2023. doi:10.1056/NEJMoa2307980. PMID 37861218.
- "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. June 2023. doi:10.1200/JCO.22.02823. PMID 36689692.
External links
- "Tarlatamab". https://www.cancer.gov/publications/dictionaries/cancer-drug/def/tarlatamab.
- "Tarlatamab (Code C175858)". https://ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI%20Thesaurus&code=C175858.
- Clinical trial number NCT05060016 for "A Phase 2 Study of Tarlatamab in Patients With Small Cell Lung Cancer (SCLC) (DeLLphi-301)" at ClinicalTrials.gov
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