Prescription medicine

Tarlatamab-dlle Brand names: Imdelltra

Tarlatamab-dlle (Imdelltra) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.

No generic listed
Boxed warning

Check it at the source: the tarlatamab-dlle FDA label on DailyMed (effective June 23, 2026, Amgen, Inc); the BLA 761344 record on Drugs@FDA; every tarlatamab-dlle label on DailyMed.

Highlights of the record

FDA label of June 23, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Boxed 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. […]

Used for

From the label: indications and usage
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.

Forms and strengths

Kit.

On the market

Earliest approval on file: May 16, 2024 Imdelltra, Amgen Inc; Drugs@FDA’s file, where older or withdrawn approvals can be missing
Generic approvals: No generic approved
Labelers listed (NDC): 1 of which 0 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC): Not in the survey
Shortage (FDA): No current entry
Recalls by its makers (FDA): No recall recorded

What is tarlatamab-dlle used for?

From the label: indications and usage
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.

Conditions named in the indications of tarlatamab-dlle's FDA labels, with every medicine labeled for each:

Lung cancer

Source: FDA drug label (IMDELLTRA (AMG757)), Amgen, Inc, effective June 23, 2026 (SPL set 1e7b6163-5d83-42ea-82c9-cf7620cdc782), via openFDA; the full label on DailyMed

What does the patient leaflet for tarlatamab-dlle say first?

The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.

From the patient leaflet: What is the most important information I should know about IMDELLTRA?
IMDELLTRA can cause serious side effects, including: Cytokine Release Syndrome (CRS). CRS is common during treatment with IMDELLTRA and can also be severe, life-threatening, or cause death. Tell your healthcare provider or get medical help right away if you develop any signs or symptoms of CRS, including: fever of 100.4°F (38°C) or higher low blood pressure tiredness fast heartbeat or dizziness headache shortness of breath or trouble breathing nausea and vomiting confusion, restlessness, or feeling anxious problems with balance and movement, such as trouble walking heart, liver, or kidney problems blood clots or unusual bleeding or bleeding that lasts a long time Due to the risk of CRS, you will receive IMDELLTRA on a "step-up dosing schedule": The step-up dosing schedule is when you receive a smaller dose of IMDELLTRA on Day 1 of your first treatment cycle (Cycle 1). You will receive the full treatment dose of IMDELLTRA on Day 8 and Day 15 of Cycle 1. You will receive the full treatment dose 1 time every 2 weeks after Day 15 of Cycle 1. If your dose of IMDELLTRA is delayed for any reason, you may need to repeat the step-up dosing schedule. Before receiving your Day 1 and Day 8 doses of Cycle 1 of IMDELLTRA, you will be given a medicine to help reduce your risk of CRS. This will be given into your vein by intravenous (IV) infusion. You will also receive IV fluids after each of your Cycle 1 Day 1 and Day 8 doses. Your healthcare provider will decide if you need to receive medicines to help reduce your risk of CRS with future doses. See " How will I receive IMDELLTRA? " for more information about how you will receive IMDELLTRA. Neurologic Problems. IMDELLTRA can cause neurologic problems that can be severe, life-threatening, or cause death. […]

From the patient leaflet: What should I avoid while receiving IMDELLTRA?
Do not drive, operate heavy or potentially dangerous machinery or do other dangerous activities, including work-related activities, during treatment with IMDELLTRA if you develop dizziness, confusion, tremors, sleepiness, or any other symptoms that impair consciousness until your signs and symptoms go away. These may be signs and symptoms of neurologic problems. See " What is the most important information I should know about IMDELLTRA " for more information about signs and symptoms of neurologic problems.

Source: FDA drug label (IMDELLTRA (AMG757)), Amgen, Inc, effective June 23, 2026 (SPL set 1e7b6163-5d83-42ea-82c9-cf7620cdc782), via openFDA; the full label on DailyMed

Is there a generic for tarlatamab-dlle (Imdelltra)?

No generic tarlatamab-dlle is approved (Drugs@FDA, October 8, 2026).

2024 earliest approval on file

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the tarlatamab-dlle label say about other medicines?

The tarlatamab-dlle label names 1 other medicine in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine named	Section	What the label says
Tocilizumab	warnings and precautions	Of the patients who experienced CRS, 31% received steroids and 10% required tocilizumab.

Check tarlatamab-dlle against other medicines

Source: FDA drug label (IMDELLTRA (AMG757)), Amgen, Inc, effective June 23, 2026 (SPL set 1e7b6163-5d83-42ea-82c9-cf7620cdc782), via openFDA; the full label on DailyMed

What next?

Check an interaction: what two or more labels say about each other