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Imdelltra is a prescription bispecific DLL3-directed CD3 T-cell engager containing tarlatamab-dlle. It is indicated for adults with extensive-stage small cell lung cancer whose disease progressed on or after platinum-based chemotherapy. FDA converted this indication from accelerated approval to traditional approval in November 2025.
read more about imdelltra ...Tarlatamab-dlle binds DLL3 on cells, including tumor cells, and CD3 on T cells. This brings the cells together, activates T cells, triggers inflammatory cytokine release, and causes lysis of DLL3-expressing cells.
Imdelltra is used in adults with extensive-stage small cell lung cancer after disease progression on or after platinum-based chemotherapy. Treatment is administered by a qualified healthcare professional in a setting prepared to manage cytokine release syndrome and neurologic toxicity.
Imdelltra is infused intravenously over one hour. Cycle 1 starts with 1 mg on day 1, followed by 10 mg on day 8 and 10 mg on day 15. After cycle 1 day 15, 10 mg is administered every two weeks until disease progression or unacceptable toxicity.
Imdelltra carries boxed warnings for cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome. Other serious concerns include low blood-cell counts, infections, liver toxicity, hypersensitivity, and fetal harm. Intensive monitoring is required around the first two doses.
Imdelltra treats extensive-stage small cell lung cancer in adults after progression on or after platinum-based chemotherapy.
The step-up regimen starts with 1 mg on cycle 1 day 1.
The regimen uses 10 mg on cycle 1 day 8 and day 15, followed by 10 mg every two weeks.
Yes. The boxed warnings concern cytokine release syndrome and neurologic toxicity, including ICANS.
DailyMed - IMDELLTRA - tarlatamab-dlle for injection. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1e7b6163-5d83-42ea-82c9-cf7620cdc782. Date Accessed October 2, 2026.
FDA Grants Traditional Approval to Tarlatamab-dlle for Extensive Stage Small Cell Lung Cancer. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-extensive-stage-small-cell-lung-cancer. Date Accessed October 2, 2026.
Tarlatamab-dlle - National Cancer Institute. https://www.cancer.gov/about-cancer/treatment/drugs/tarlatamab-dlle. Date Accessed October 2, 2026.
Tarlatamab-dlle Injection - MedlinePlus Drug Information. https://www.medlineplus.gov/druginfo/meds/a624037.html. Date Accessed October 2, 2026.
Tarlatamab in Small-Cell Lung Cancer After Platinum-Based Chemotherapy. https://pubmed.ncbi.nlm.nih.gov/40454646/. Date Accessed October 2, 2026.