Tarlatamab

Tarlatamab-dlle is a bispecific T-cell engager that binds to DLL3 expressed on the surface of cells, including tumor cells, and CD3 expressed on the surface of T cells. Tarlatamab-dlle causes T-cell activation, release of inflammatory cytokines, and lysis of DLL3-expressing cells.

• IMDELLTRA is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA is a bispecific delta-like ligand 3 (DLL3)-directed CD3 T- cell engager indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum - based chemotherapy.ICD-10: C34.90

• None . None.contraindicated

Administer as an intravenous infusion over 1 hour. ( 2.2 ) Administer IMDELLTRA according to the step - up dosing schedule in Table 1 to reduce the risk of cytokine release syndrome. ( 2.2 ) Administer concomitant medications as recommended. ( 2.3 ) Monitor patients from the start of the IMDELLTRA infusion for 22 to 24 hours on Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting. Recommend patients to remain within 1 hour of an appropriate healthcare setting for a total of 48 hours from the start of the infusion with IMDELLTRA following Cycle 1 Day 1 and Cycle 1 Day 8 doses, accompanied by a caregiver. ( 2.2 ) See Full Prescribing Information for instructions on preparation and administration. ( 2.2 , 2.6 ) 2.1 Important Dosage and Administration Information Administer IMDELLTRA according to the step-up dose and schedule in Table 1 to reduce the incidence and severity of cytokine release syndrome (CRS) [see Dosage and Administration (2.2) ] . Evaluate complete blood count, liver enzymes and bilirubin prior to administration of all doses of IMDELLTRA up through Cycle 5 Day 15 and then prior to administration of IMDELLTRA on Day 1 of each cycle starting with Cycle 6. More frequent evaluation may be necessary if clinically indicated [see Warnings and Precautions (5.3 , 5.5) ] . Ensure patients are well hydrated prior to administration of IMDELLTRA [see Warnings and Precautions (5.1) ] .

Cytopenias : Monitor complete blood counts prior to administration of all doses of IMDELLTRA up through Cycle 5 Day 15 and then prior to administration of IMDELLTRA on Day 1 of each cycle starting with Cycle 6. More frequent evaluation may be necessary as clinically indicated. Withhold or permanently discontinue based on severity. ( 5.3 ) Infections : Monitor for signs and symptoms of infection; treat appropriately. Withhold or permanently discontinue based on severity. ( 5.4 ) Hepatotoxicity : Monitor liver enzymes and bilirubin prior to administration of all doses of IMDELLTRA up through Cycle 5 Day 15 and then prior to administration of IMDELLTRA on Day 1 of each cycle starting with Cycle 6. More frequent evaluation may be necessary as clinically indicated. Withhold or permanently discontinue based on severity. ( 5.5 ) Hypersensitivity : Monitor for signs and symptoms of hypersensitivity and treat accordingly. Withhold or permanently discontinue based on severity. ( 5.6 ) Embryo - Fetal Toxicity : May cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception ( 5.7 , 8.1 , 8.3 ) 5.1 Cytokine Release Syndrome IMDELLTRA can cause cytokine release syndrome (CRS) including life-threatening or fatal reactions. In the pooled safety population [see Adverse Reactions (6.1) ] , CRS occurred in 57% (268/473) of patients who received IMDELLTRA, including 39% Grade 1, 15% Grade 2, 1.7% Grade 3 and 0.2% Grade 4.

The following clinically significant adverse reactions are described elsewhere in the labeling: Cytokine Release Syndrome (CRS) [see Warnings and Precautions (5.1) ] Neurologic Toxicity Including ICANS [see Warnings and Precautions (5.2) ] Cytopenias [see Warnings and Precautions (5.3) ] Infections [see Warnings and Precautions (5.4) ] Hepatotoxicity [see Warnings and Precautions (5.5) ] Hypersensitivity [see Warnings and Precautions (5.6) ] The most common adverse reactions (> 20%) were cytokine release syndrome, fatigue, decreased appetite, anemia, dysgeusia, pyrexia, constipation, musculoskeletal pain, and nausea. The most common (≥ 5%) Grade 3 or 4 laboratory abnormalities were decreased lymphocytes, decreased sodium, decreased total neutrophils, and increased uric acid. To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Lactation : Advise not to breastfeed. ( 8.2 ) 8.1 Pregnancy Risk Summary Based on its mechanism of action, IMDELLTRA may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on the use of IMDELLTRA in pregnant women to inform a drug-associated risk. In an animal reproduction study, a murine surrogate molecule administered intravenously to pregnant mice crossed the placental barrier . Tarlatamab-dlle causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. Human immunoglobulin G (IgG) and proteins comprising IgG-derived fragment crystallizable (Fc) domains are known to cross the placental barrier; therefore, IMDELLTRA has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% - 4% and 15% - 20%, respectively. Data Animal Data Animal reproduction studies have not been conducted with tarlatamab-dlle. In an embryo-fetal developmental toxicity study, a murine surrogate molecule was administered intravenously to pregnant mice during the period of organogenesis.

Metabolism

Tarlatamab-dlle pharmacokinetic data in patients with SCLC at the approved recommended dosage are presented as mean (CV%) unless otherwise specified. The exposure of tarlatamab-dlle increases in a dose proportional manner over the dosage range of 1 mg to 100 mg (10 times the highest approved recommended dosage) every 2 weeks.

• May 16, 2024BLABLA761344Amgen Inc

1. 1Cytokine Release Syndrome343%
2. 2Immune Effector Cell-associated Neurotoxicity Syndrome343%
3. 3Acute Respiratory Failure229%
4. 4Dyspnoea229%
5. 5Pain229%
6. 6Asthenia114%
7. 7Atrial Fibrillation114%
8. 8Cardio-respiratory Arrest114%
9. 9Chest Pain114%
10. 10Chills114%
11. 11Depressed Mood114%
12. 12Distributive Shock114%
13. 13Drug Ineffective114%
14. 14Fatigue114%
15. 15Haemoglobin Decreased114%

The 10 most recently updated of 36 ClinicalTrials.gov registrations naming Tarlatamab as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study of Hospital-at-Home for People Receiving Tarlatamab
  Recruiting · Interventional · 70 enrolled · Memorial Sloan Kettering Cancer Center
  NCT06957314updated 2026-06-12
• A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)
  Recruiting · Phase 3 · Interventional · 330 enrolled · Amgen
  NCT07005128updated 2026-06-12
• Tarlatamab and Durvalumab vs. Durvalumab Alone for Limited-Stage-Small Cell Lung Cancer
  Not yet recruiting · Phase 3 · Interventional · 430 enrolled · PrECOG, LLC.
  NCT07637513updated 2026-06-09
• A Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2
  Recruiting · Phase 2 · Interventional · 48 enrolled · ETOP IBCSG Partners Foundation
  NCT07203053updated 2026-06-09
• SCLC Tarlatamab Blood Collection
  Not yet recruiting · Observational · 25 enrolled · Duke University
  NCT07468656updated 2026-06-03
• A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311)
  Recruiting · Phase 1 · Interventional · 380 enrolled · Amgen
  NCT07037758updated 2026-05-29
• Study of Tarlatamab + ZL-1310 +/- Anti-programmed Death Ligand 1 (Anti-PD-L1) in Small Cell Lung Cancer (SCLC)
  Recruiting · Phase 1 · Interventional · 160 enrolled · Amgen
  NCT07531095updated 2026-05-29
• Subcutaneous Tarlatamab in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-308)
  Recruiting · Phase 1 · Interventional · 220 enrolled · Amgen
  NCT06598306updated 2026-05-29
• Combination of Tarlatamab and Temozolomide in Patients With Central Nervous System Tumors
  Recruiting · Phase 1 · Phase 2 · Interventional · 70 enrolled · Centre Leon Berard
  NCT07243470updated 2026-05-27
• A Study of GSK5764227 in Participants With Advanced Solid Tumors (EMBOLD)
  Recruiting · Phase 1 · Interventional · 845 enrolled · GlaxoSmithKline
  NCT06551142updated 2026-05-22

Frequently asked questions

How does Tarlatamab work?

Tarlatamab-dlle is a bispecific T-cell engager that binds to DLL3 expressed on the surface of cells, including tumor cells, and CD3 expressed on the surface of T cells. Tarlatamab-dlle causes T-cell activation, release of inflammatory cytokines, and lysis of DLL3-expressing cells.

What is Tarlatamab used for?

According to FDA labeling, Tarlatamab carries indications including: IMDELLTRA is indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy. IMDELLTRA is a bispecific delta-like ligand 3 (DLL3)-directed CD3 T- cell engager indicated for the treatment of adult patients with extensive stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum - based chemotherapy.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Tarlatamab?

Tarlatamab is classified as Other monoclonal antibodies and antibody drug conjugates, Antibody-Surface Protein Interactions, CD3-directed Antibody Interactions, Increased Cytokine Production.

What are the brand names for Tarlatamab?

Tarlatamab is marketed under brand names including Imdelltra.

What are the contraindications for Tarlatamab?

Tarlatamab labeling lists contraindications including: None . None.. Always consult the full prescribing information and a clinician.