Last reviewed 2026-04-20 · How we verify

Imdelltra (Amg757) (TARLATAMAB)

Imdeldtra works by binding to a specific target on cancer cells, which helps to slow or stop the growth of the cancer.

TARLATAMAB, marketed as Imdelltra (Amg757) by Amgen Inc, is approved for the treatment of ES-SCLC with disease progression. Its key strength lies in its mechanism of action, which binds to a specific target on cancer cells to inhibit their growth, offering a targeted therapy option. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.

At a glance

Mechanism of action

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. Tarlatamab-dlle had anti-tumor activity in mouse models of SCLC.

Approved indications

• ES-SCLC with disease progression

Boxed warnings

• WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Initiate IMDELLTRA using the step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA until CRS resolves or permanently discontinue based on severity [see Dosage and Administration (2.5) and Warnings and Precautions (5.1) ] . Neurologic toxicity and immune effector cell-associated neurotoxicity syndrome (ICANS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Monitor patients for signs and symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA until ICANS resolves or permanently discontinue based on severity [see Dosage and Administration (2.5) and Warnings and Precautions (5.2) ] . WARNING: CYTOKINE RELEASE SYNDROME and NEUROLOGIC TOXICITY including IMMUNE EFFECTOR CELL-ASSOCIATED NEUROTOXICITY SYNDROME See full prescribing information for complete boxed warning . Cytokine release syndrome (CRS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Initiate treatment with the IMDELLTRA using step-up dosing schedule to reduce the incidence and severity of CRS. Withhold IMDELLTRA until CRS resolves or permanently discontinue based on severity. ( 2.5 , 5.1 ) Neurologic toxicity and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), including life-threatening or fatal reactions, can occur in patients receiving IMDELLTRA. Monitor patients for signs or symptoms of neurologic toxicity, including ICANS, during treatment and treat promptly. Withhold IMDELLTRA until ICANS resolves or permanently discontinue based on severity. ( 2.5 , 5.2 )

Common side effects

• Cytokine release syndrome
• Fatigue
• Decreased appetite
• Dysgeusia
• Pyrexia
• Constipation
• Musculoskeletal pain
• Nausea
• Decreased lymphocytes
• Decreased sodium
• Decreased total neutrophils
• Increased uric acid

Key clinical trials

• Bispecific T-Cell Engager Tarlatamab and TROP2 Targeted Antibody Drug Conjugate Sacituzumab Govitecan in Previously Treated Extensive-Stage Small Cell Lung Cancer and Extrapulmonary Neuroendocrine Cancer (PHASE1,PHASE2)
• A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC) (PHASE3)
• A Study of Hospital-at-Home for People Receiving Tarlatamab (NA)
• A Study of Tarlatamab in Combination With AB248 in Participants With Extensive Stage Small Cell Lung Cancer (DeLLphi-311) (PHASE1)
• A Trial of Tarlatamab in Patients With Pretreated Extensive-stage Small Cell Lung Cancer (ES-SCLC) and ECOG PS 2 (PHASE2)
• Tarlatamab in Advanced Delta-like 3 (DLL3)-Expressing Tumors Including Neuroendocrine Neoplasms (PHASE2)
• A Study of Tarlatamab for People With Prostate Cancer (PHASE2)
• SCLC Tarlatamab Blood Collection

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• Imdelltra (Amg757) CI brief — competitive landscape report
• Imdelltra (Amg757) updates RSS · CI watch RSS
• Amgen Inc portfolio CI