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Tarlatamab

Not yet reviewed: Listed from FDA or ClinicalTrials.gov records; an editor has not checked it yetListed from FDA or ClinicalTrials.gov records; an editor has not checked it yet.

Also known as Imdelltra, Tarlatamab-dlle

AMGEN INC AMGN · Small Cell Lung Cancer; Small-cell Lung Cancer; Extensive Stage Small-cell Lung Cancer; Extensive-Stage Small-Cell Lung Cancer; Limited Stage Small Cell Lung Cancer

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Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Approved

    Not recorded

  • Linked trials

    5

    From ClinicalTrials.gov

  • Latest FDA action

    Approved

    BLA761344,

Recalls, shortages, patents and EU status at a glance

Key information

Sponsor
AMGEN INC AMGN Source: Company record for AMGEN INC (opens in a new tab)
Indications
Small Cell Lung Cancer; Small-cell Lung Cancer; Extensive Stage Small-cell Lung Cancer; Extensive-Stage Small-Cell Lung Cancer; Limited Stage Small Cell Lung Cancer Source: Conditions from ClinicalTrials.gov (opens in a new tab)
Application
BLA 761344 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for BLA 761344 (opens in a new tab)
Designations
None recorded
Next catalyst
None scheduled

Development timeline

  1. Preclinical Completed
  2. Phase 1 Completed
  3. Phase 2 Completed
  4. Phase 3 CompletedFirst trial start 31 May 20235 linked trials
  5. Filed Completed
  6. Approved Current stageFirst approval 16 May 2024

Overview

Mechanism
Not recorded
Route
Not recorded
Modality
Not recorded
Specialties
Not recorded

Overview text is written by HealthTrade editors.

Key dates

No catalysts yet. Editors add each date together with its source.

FDA designations

No FDA designations are on record for Tarlatamab. Editors add each one with its source.

Filed application

No filed application is on record for Tarlatamab. Approvals are listed under FDA actions.

FDA advisory committees

No FDA advisory committee meetings are on record for Tarlatamab.

Clinical trials

Trials linked to Tarlatamab
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT07778316ClinicalTrials.gov record for NCT07778316 (opens in a new tab)DeLLphi-315Phase 3 Trial of Tarlatamab (SC vs IV) in Extensive-Stage Small Cell Lung Cancer After Platinum Based First-line Chemotherapy (ES-SCLC)Phase 3Recruiting400 (estimated)24 Sep 2027 (estimated) No
NCT07005128ClinicalTrials.gov record for NCT07005128 (opens in a new tab)DeLLphi-312A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)Phase 3Active, not recruiting350 (actual)4 Jan 2029 (estimated) No
NCT06211036ClinicalTrials.gov record for NCT06211036 (opens in a new tab)DeLLphi-305Study Comparing Tarlatamab and Durvalumab Versus Durvalumab Alone in First-Line Extensive-Stage Small-Cell Lung Cancer (ES-SCLC) Following Platinum, Etoposide and DurvalumabPhase 3Active, not recruiting563 (actual)5 Jul 2027 (estimated) No

Publications listing DeLLphi-305 (1), newest first

  1. Safety and activity of tarlatamab in combination with a PD-L1 inhibitor as first-line maintenance therapy after chemo-immunotherapy in patients with extensive-stage small-cell lung cancer (DeLLphi-303): a multicentre, non-randomised, phase 1b study.

    The Lancet. Oncology · 2025 Oct

    PubMed 40934933 (opens in a new tab)DOI 10.1016/S1470-2045(25)00480-2 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

NCT06117774ClinicalTrials.gov record for NCT06117774 (opens in a new tab)DeLLphi-306Study Evaluating Tarlatamab After Chemoradiotherapy in Limited-Stage Small-Cell Lung Cancer (LS-SCLC)Phase 3Active, not recruiting404 (actual)20 Apr 2030 (estimated) No
NCT05740566ClinicalTrials.gov record for NCT05740566 (opens in a new tab)DeLLphi-304Study Comparing Tarlatamab With Standard of Care Chemotherapy in Relapsed Small Cell Lung CancerPhase 3Active, not recruiting509 (actual)29 Jan 2025 (actual) Yes First posted Results on ClinicalTrials.gov for NCT05740566 (opens in a new tab)

Posted results on ClinicalTrials.gov for DeLLphi-304

  • Overall Survival (OS) (months)
    • Standard of Care (SOC) vs Tarlatamab 1 mg to 10 mg Q2W: Hazard Ratio (HR) 0.599 (95% CI 0.468 to 0.768), p-value <0.001, Stratified log-rank test, superiority

Serious adverse events (All-cause mortality: from randomization up to primary completion DCO date 29 January 2025; median (min, max) time was 8.6 (0.1, 18.5) months. Adverse events were collected from first dose of drug up to last dose + 65 days up to primary completion DCO date 29 January 2025; median (min, max) time was 5.3 (0.1, 17.3) months.): Standard of Care (SOC) 125 of 244; Tarlatamab 1 mg to 10 mg Q2W 129 of 252

Source: ClinicalTrials.gov results for NCT05740566 (opens in a new tab)· imported

Posted results as ClinicalTrials.gov prints them: primary outcome analyses and serious adverse event totals only. Registry facts, not reviewed by HealthTrade and not investment advice; filing-derived results are listed separately.

Publications listing DeLLphi-304 (3), newest first

  1. Matching-Adjusted Indirect Comparison of Tarlatamab for Patients with Platinum-Refractory or Platinum-Resistant Extensive-Stage Small-Cell Lung Cancer.

    Advances in therapy · 2026 Sep

    PubMed 42377743 (opens in a new tab)DOI 10.1007/s12325-026-03659-4 (opens in a new tab)

  2. Tarlatamab in Small-Cell Lung Cancer after Platinum-Based Chemotherapy.

    The New England journal of medicine · 2025 Jul 24

    PubMed 40454646 (opens in a new tab)DOI 10.1056/NEJMoa2502099 (opens in a new tab)

  3. Plain language summary: tarlatamab for patients with previously treated small cell lung cancer.

    Future oncology (London, England) · 2024 Dec

    PubMed 39530627 (opens in a new tab)DOI 10.1080/14796694.2024.2402152 (opens in a new tab)

Citations from PubMed, U.S. National Library of Medicine; abstracts are not stored. A publication lists this study’s NCT number and may be a review that cites many studies.

Source: ClinicalTrials.gov, U.S. National Library of Medicine. Posted results are shown as ClinicalTrials.gov prints them; results from company and journal sources are entered by editors and listed separately. Full result tables are on ClinicalTrials.gov.

Trial quality

About CT-VCA

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FDA actions

Original approvals and new-indication supplements for Tarlatamab, newest first
ApplicationActionDateOutcomeReviewSource
BLA761344Action letter for BLA761344 (opens in a new tab) Supplement 1 EfficacyApprovedpriorityDrugs@FDA via openFDA (opens in a new tab)
BLA761344Action letter for BLA761344 (opens in a new tab) Original 1 Type 1 - New Molecular EntityApprovedpriorityDrugs@FDA via openFDA (opens in a new tab)

Data provided by the U.S. Food and Drug Administration.

FDA recalls load here.

FDA drug shortages load here.

Orange Book patents load here.

FAERS adverse event counts load here.

Papers and preprints load here.

Community discussion loads here.

EU status (EMA)

AuthorisedOrphan medicine

Imdylltra (EMEA/H/C/006451)

Authorised
Therapeutic area
Small Cell Lung Carcinoma
Marketing authorisation holder
Amgen Europe B.V.
Active substance (INN)
tarlatamab
ATC code
L01FX33

Matched by active substance: EMA's INN or active substance equals this drug's name.

EMA page for Imdylltra (opens in a new tab)EMA medicine data (opens in a new tab)

Source: European Medicines Agency (EMA), medicines data download. Licence: EMA re-use with acknowledgement. EMA medicines report 2026-10-26.

Related news

Sources

Record updated .

Dates come from company and FDA disclosures and can change. Nothing on this page is investment advice.