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IMDELLTRA tarlatamab-dlle APPROVED
Drug Profile
ModalityBispecific T-cell engager (BiTE)
RouteIV
Therapy AreaOncology
Launch2024-05-16
Peak Sales Est$4000M
Formulations[{"id":"imdelltra-iv","doses":"10mg IV Q2W (step-up: 1mg Day 1, 10mg Day 8, then Q2W)","route":"IV",
Companies
AMGN (ORIGINATOR)100%
Mechanism: DLL3-targeting BiTE (bispecific T-cell engager)
Expert: Half-life extended bispecific T-cell engager targeting DLL3 (delta-like ligand 3) on tumor cells and CD3 on T cells. DLL3 is expressed on >80% of SCLC tumors with minimal normal tissue expression.
Everyday: A two-headed molecule: one end grabs onto a marker (DLL3) found almost exclusively on small-cell lung cancer cells, while the other end grabs a T-cell and pulls it close. This forces your immune system to attack the cancer directly.
Targets: ["DLL3"]
Revenue History
PeriodRevenue ($M)
2024$115M
2025$627M
Q4 2024$67M
Q4 2025$234M
Programs (2)
IndicationStageKey StudyRegional Status
ES-SCLC 2L+APPROVEDDeLLphi-301/304[{"stage":"APPROVED","region":"US","approval_date":"2024-05-16"}]
ES-SCLC 1LPHASE3DeLLphi-308/312[]
Upcoming Catalysts (1)
IMDELLTRA - 1L ES-SCLC - Ph3 Data (DeLLphi-308/312) 2027
Notes
KEY GROWTH DRIVER. +445% YoY in FY2025. DeLLphi-304: 40% OS reduction (HR 0.60) in 2L+ ES-SCLC. Full approval Nov 2025. Moving to 1L maintenance (DeLLphi-308) and 1L induction (DeLLphi-312). Potential $3-5B franchise if 1L data positive.
Data from Supabase · Updated 2026-03-24