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Retifanlimab

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 Zynyz, Retifanlimab-dlwr

INCYTE CORP INCY · Metastatic Nonsquamous Non-Small Cell Lung Cancer; Metastatic Squamous Non-Small Cell Lung Cancer; Non-small Cell Lung Cancer; Squamous Cell Carcinoma of the Anal Canal

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Key figures

  • Next catalyst

    None scheduled

    Only dates with a source are listed

  • Phase

    Approved

    Not recorded

  • Linked trials

    3

    From ClinicalTrials.gov

  • Latest FDA action

    Approved

    BLA761334,

Recalls, shortages, patents and EU status at a glance

Key information

Sponsor
INCYTE CORP INCY Source: Company record for INCYTE CORP (opens in a new tab)
Indications
Metastatic Nonsquamous Non-Small Cell Lung Cancer; Metastatic Squamous Non-Small Cell Lung Cancer; Non-small Cell Lung Cancer; Squamous Cell Carcinoma of the Anal Canal Source: Conditions from ClinicalTrials.gov (opens in a new tab)
Application
BLA 761334 · Priority review Source: Drugs@FDA via openFDA (opens in a new tab) · Action letter for BLA 761334 (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 Jul 20203 linked trials
  5. Filed Completed
  6. Approved Current stageFirst approval 22 Mar 2023

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 Retifanlimab. Editors add each one with its source.

Filed application

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

FDA advisory committees

No FDA advisory committee meetings are on record for Retifanlimab.

Clinical trials

Trials linked to Retifanlimab
TrialTitlePhaseStatusEnrollmentPrimary completionResults posted
NCT04472429ClinicalTrials.gov record for NCT04472429 (opens in a new tab)Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2).Phase 3Completed308 (actual)15 Apr 2024 (actual) Yes First posted Results on ClinicalTrials.gov for NCT04472429 (opens in a new tab)

Posted results on ClinicalTrials.gov for NCT04472429

  • Progression-free Survival (PFS) (months)
    • Retifanlimab 500 mg Q4W + Chemotherapy vs Placebo + Chemotherapy: Hazard Ratio (HR) 0.63 (95% CI 0.47 to 0.84), p-value 0.0006, stratified log-rank test, superiority

Serious adverse events (up to approximately 57 months): Placebo + Chemotherapy 59 of 152; Retifanlimab 500 mg Q4W + Chemotherapy 73 of 154; Randomized Period Total 132 of 306; Retifanlimab 500 mg Q4W 19 of 77

Source: ClinicalTrials.gov results for NCT04472429 (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 NCT04472429 (2), newest first

  1. Retifanlimab with carboplatin and paclitaxel for locally recurrent or metastatic squamous cell carcinoma of the anal canal (POD1UM-303/InterAACT-2): a global, phase 3 randomised controlled trial.

    Lancet (London, England) · 2025 Jun 14

    PubMed 40517007 (opens in a new tab)DOI 10.1016/S0140-6736(25)00631-2 (opens in a new tab)

  2. POD1UM-303/InterAACT 2: A phase III, global, randomized, double-blind study of retifanlimab or placebo plus carboplatin-paclitaxel in patients with locally advanced or metastatic squamous cell anal carcinoma.

    Frontiers in oncology · 2022

    PubMed 36091159 (opens in a new tab)DOI 10.3389/fonc.2022.935383 (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.

NCT04205812ClinicalTrials.gov record for NCT04205812 (opens in a new tab)POD1UM-304Platinum-Based Chemotherapy With/Without INCMGA00012, an Anti-PD-1 Antibody, in Non-Small Cell Lung CancerPhase 3Completed583 (actual)15 Dec 2023 (actual) Yes First posted Results on ClinicalTrials.gov for NCT04205812 (opens in a new tab)

Posted results on ClinicalTrials.gov for POD1UM-304

  • Overall Survival (months)
    • Placebo + Chemotherapy vs Retifanlimab + Chemotherapy: Hazard Ratio (HR) 0.75 (95% CI 0.60 to 0.93), p-value 0.0042, Log Rank, superiority

Serious adverse events (up to approximately 3.25 years): Retifanlimab + Chemotherapy 158 of 389; Placebo + Chemotherapy 57 of 190; Randomized Treatment Period Total 215 of 579; Retifanlimab Monotherapy 12 of 59

Source: ClinicalTrials.gov results for NCT04205812 (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 POD1UM-304 (1), newest first

  1. Retifanlimab versus placebo in combination with platinum-based chemotherapy in patients with first-line non-squamous or squamous metastatic non-small-cell lung cancer (POD1UM-304): a phase 3, multiregional, placebo-controlled, double-blind, randomised study.

    The Lancet. Respiratory medicine · 2025 Dec

    PubMed 40983066 (opens in a new tab)DOI 10.1016/S2213-2600(25)00209-7 (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.

NCT04203511ClinicalTrials.gov record for NCT04203511 (opens in a new tab)INCMGA00012 in Combination With Chemoradiation in Participants With Stage III Non-Small Cell Lung Cancer (POD1UM-301)Phase 3Withdrawn0 (actual)30 Nov 2023 (estimated) No

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 Retifanlimab, newest first
ApplicationActionDateOutcomeReviewSource
BLA761334Action letter for BLA761334 (opens in a new tab) Supplement 9 EfficacyApprovedstandardDrugs@FDA via openFDA (opens in a new tab)
BLA761334Action letter for BLA761334 (opens in a new tab) Supplement 8 EfficacyApprovedstandardDrugs@FDA via openFDA (opens in a new tab)
BLA761334Action letter for BLA761334 (opens in a new tab) Supplement 5 EfficacyApprovedstandardDrugs@FDA via openFDA (opens in a new tab)
BLA761334Action letter for BLA761334 (opens in a new tab) Supplement 4 EfficacyApprovedpriorityDrugs@FDA via openFDA (opens in a new tab)
BLA761334Action letter for BLA761334 (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

Zynyz (EMEA/H/C/006194)

Authorised
Therapeutic area
Carcinoma, Merkel Cell
Marketing authorisation holder
Incyte Biosciences Distribution B.V.
Active substance (INN)
retifanlimab
ATC code
L01FF10
Latest EMA decision

Matched by active substance: EMA's INN or active substance equals this drug's name. EMA lists 1 other product with this substance, such as generics.

EMA page for Zynyz (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

No recent headlines mention this drug.

Sources

Record updated .

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