Tarlatamab is a prescription medicine 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. It is available as kits. MedsAcross supplies Tarlatamab for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
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.
Source: US FDA prescribing information
Administer as an intravenous infusion over 1 hour. Administer IMDELLTRA according to the step - up dosing schedule in Table 1 to reduce the risk of cytokine release syndrome. Administer concomitant medications as recommended. Monitor patients from the start of the IMDELLTRA infusion for 6 to 8 hours on Cycle 1 Day 1 and Cycle 1 Day 8 in an appropriate healthcare setting. Perform patient assessment including vital signs check on Cycle 1 Days 2 and 9. 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. See Full Prescribing Information for instructions on preparation and administration.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
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. 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. Infections: Monitor for signs and symptoms of infection, treat appropriately.
Source: US FDA prescribing information
The following clinically significant adverse reactions are described elsewhere in the labeling: Cytokine Release Syndrome (CRS) Neurologic Toxicity Including ICANS Cytopenias Infections Hepatotoxicity Hypersensitivity The most common adverse reactions (> 20%) were cytokine release syndrome, fatigue, decreased appetite, 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.
Source: US FDA prescribing information
Store IMDELLTRA and IV Solution Stabilizer (IVSS) vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light until time of use. Do not freeze. IMDELLTRA and IV Solution Stabilizer (IVSS) vials may be kept at room temperature between 20°C to 25°C (68°F to 77°F) for up to 24 hours in the original carton to protect from light.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
1 presentations of Tarlatamab, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Imdelltra (AMG757) kit Cold chain | Amgen | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 1 presentations of Tarlatamab and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Tarlatamab, including Imdelltra (AMG757).
Yes. The US FDA first approved Tarlatamab on 16 May 2024, according to Drugs@FDA.
Yes. Tarlatamab has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
At least one listed presentation of Tarlatamab must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Tarlatamab is classified under ATC code L01FX33 (Tarlatamab).
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