Tarlatamab
The first T-cell engager to improve survival in a common solid tumour, small-cell lung cancer.
Accelerated approval May 2024 (DeLLphi-301, ORR 40%); DeLLphi-304 phase 3 (2025) showed OS 13.6 vs 8.3 months versus chemotherapy in second-line SCLC, converting to full approval. First-line combination with PD-L1 (DeLLphi-305) and limited-stage trials ongoing. CRS in ~50% (mostly grade 1-2); step-up dosing with monitoring.
Tarlatamab is a half-life-extended BiTE; intact IgG shown as reference.
1.One arm binds DLL3 on the tumour cell
- Route
- IV infusion over 1 hour
- Schedule
- Step-up: 1 mg on cycle 1 day 1, then 10 mg on day 8 and every 2 weeks thereafter
- Dose modifications
- Hold for grade 2 CRS/ICANS until resolved; dexamethasone premedication and IV fluids for first two doses
- Monitoring
- Inpatient monitoring 22-24 h after first two doses; temperature, blood pressure, neurology; ICE score
Source: US prescribing information (DailyMed). Doses are for orientation; the current label governs.
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Step-up dosing is often started in hospital (Part A) because of cytokine release syndrome monitoring, then continued in the outpatient setting. First DLL3 engager for small-cell lung cancer (2024).
- Commercial insurance
- covered with prior authorisation
Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.
- Assistance programmes
- Amgen SupportPlus
- Amgen Safety Net Foundation
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Notes
- No UK marketing authorisation as of September 2026 (EU MAA under review); accessible only via trials or early access.
- NHS England
- Not routinely funded
Sources: NICE search: tarlatamab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- Nov 2022DesignationUS
Breakthrough Therapy designation, ES-SCLC after platinum source
- 16 May 2024ApprovalUS
Accelerated approval, ES-SCLC after platinum (DeLLphi-301) source
- Jun 2025Filing / dealUS
Phase 3 DeLLphi-304 OS benefit presented; conversion to full approval pursued source
- Dec 2025ApprovalUS
Full approval based on DeLLphi-304 source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2024 | Extensive-stage SCLC after platinum chemotherapy |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Cytokine release syndrome DeLLphi-301, n=187 | 55% | 1.6% |
| Haemoglobin decreased DeLLphi-301, n=187 | 58% | 5% |
| Fatigue DeLLphi-301, n=187 | 51% | 10% |
| Dysgeusia DeLLphi-301, n=187 | 36% | 0% |
| Pyrexia DeLLphi-301, n=187 | 36% | 0% |
| Decreased appetite DeLLphi-301, n=187 | 34% | 2.7% |
| Musculoskeletal pain DeLLphi-301, n=187 | 30% | 1.1% |
| Constipation DeLLphi-301, n=187 | 30% | 0.5% |
| Nausea DeLLphi-301, n=187 | 22% | 1.6% |
| Neurologic toxicity incl. ICANS Boxed warning; ICANS in a minority, mostly grade 1-2 | — | — |
Rates read from the US prescribing information. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare Part B (physician-administered); commercial plans per formulary | not disclosed | amgensupportplus.com |
| United Kingdom | NICE: appraisal for ES-SCLC after platinum in progress (2026) | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
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