IMDELLTRA (tarlatamab-dlle)
IMDELLTRA is indicated for the treatment of Small Cell Lung Cancer.
How IMDELLTRA Works
Tarlatamab-dlle is a bispecific molecule that binds to DLL3 expressed on tumor cells and CD3 expressed on T cells. By bridging these two cells, the drug triggers T-cell activation and the release of inflammatory cytokines. This interaction results in the lysis of DLL3-expressing cells, demonstrating anti-tumor activity in small cell lung cancer models.
Details
- Status
- Prescription
- First Approved
- 2024-05-16
- Patent Cliff
- 2031
- Revenue
- $178M (Q3-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
IMDELLTRA Approval History
What IMDELLTRA Treats
1 indicationsIMDELLTRA is approved for 1 conditions since its original approval in 2024. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Small Cell Lung Cancer
IMDELLTRA 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) ] . Neuro...
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 )
IMDELLTRA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in IMDELLTRA's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications IMDELLTRA treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to IMDELLTRA
3 of 8FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
IMDELLTRA FDA Label Details
Indications & Usage
FDA Label (PDF)IMDELLTRA is indicated for the treatment of Small Cell Lung Cancer.
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 ...
Pro Intelligence Preview
Deep insights for IMDELLTRA
Revenue Insights
- • Q3-2025: $178M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2031
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • 8 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.