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Drug

Retifanlimab

Approved · FDA / EMA
Emerging researchLate-stage development

Also known as Zynyz.

RxNorm2632981UNII2Y3T5IF01Z
1
Research papers
26
Active clinical trials
7
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 1/2, Open-Label, Multicenter Study of INCB177054 in Participants With Select Advanced or Metastatic Solid Tumors

Clinical trial2026-07-30Primary completion · ClinicalTrials.gov

Phase I/II Study of the Combination Immunotherapy Regimen: SX-682, TriAdeno Vaccine, Retifanlimab and IL-15 Agonist N-803 (STAR15) for Metastatic Colorectal Cancer (mCRC)

Clinical trial2026-07-09Results expected Q4 2027 · ClinicalTrials.gov

A Phase Ib/II Study of Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced Solid Tumors

Clinical trial2026-07-08Results expected Q2 2027 · ClinicalTrials.gov

A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non-Small Cell Lung Cancer (POD1UM-304)

Clinical trial2026-07-06Results posted · ClinicalTrials.gov

NIMBLE-CRC: NeoImmunoModulation Before Leveraging Excision in Colorectal Rectal Cancer

Clinical trial2026-07-01Results expected Q3 2028 · ClinicalTrials.gov

ctHPVDNA Adapted ChemoRadiation +/- Retifanlimab Treatment in Locally-Advanced Anal Cancer (CHART-AC)

Clinical trial2026-06-26Results expected Q1 2029 · ClinicalTrials.gov

Phase I/IIa Trial of Retifanlimab and Difluoromethylornithine (DFMO) in Patients With Progressive High-Grade Glioma

Clinical trial2026-06-24Results expected Q4 2030 · ClinicalTrials.gov

Indication expansion: RETIFANLIMAB-DLWR (BLA761334)

Regulatory2026-05-18FDA

Indication expansion: RETIFANLIMAB-DLWR (BLA761334)

Regulatory2026-03-30FDA

Indication expansion: RETIFANLIMAB-DLWR (BLA761334)

Regulatory2025-12-17FDA

Indication expansion: RETIFANLIMAB-DLWR (BLA761334)

Regulatory2025-05-15FDA

A phase II study of retifanlimab (INCMGA00012) in patients with squamous carcinoma of the anal canal who have progressed following platinum-based chemotherapy (POD1UM-202).

Research2022-07-08ESMO open

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Retifanlimab
Aliases & brands
Zynyz
RxNorm CUI
2632981
UNII
2Y3T5IF01Z
Regulatory jurisdictions
fdaema

Regulatory timeline

7 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2023-03-22 → 2024-04-19)
Earliest approval
2023-03-22
Latest approval
2026-05-18
Authorities
FDA · EMA
Total events
7
fdaU.S. Food and Drug Administration· 6 events
2026-05-18Indication expansion
Indication expansion: RETIFANLIMAB-DLWR (BLA761334)
Evidence ↗
2026-03-30Indication expansion
Indication expansion: RETIFANLIMAB-DLWR (BLA761334)
Evidence ↗
2025-12-17Indication expansion
Indication expansion: RETIFANLIMAB-DLWR (BLA761334)
Evidence ↗
emaEuropean Medicines Agency· 1 event
2024-04-19ApprovalMulti-authority
Approval: Zynyz (EMA)
Indication: Squamous cell carcinoma of the anal canal (SCAC) Zynyz is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic… Show full indication

Squamous cell carcinoma of the anal canal (SCAC) Zynyz is indicated in combination with carboplatin and paclitaxel for the first-line treatment of adult patients with metastatic or with inoperable locally recurrent squamous cell carcinoma of the anal canal (SCAC). Merkel cell carcinoma (MCC)  Zynyz is indicated as monotherapy for the first line treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC) not amenable to curative surgery or radiation therapy.

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

54 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
54
registered trials across all phases
LATEST COMPLETION 2026
26
Active studies
18
Recruiting
5
Late-stage (III+)
16
Completed
12
Discontinued
PHASE DISTRIBUTIONn = 54
Early Phase 11Phase 115Phase 1 / 210Phase 223Phase 2 / 31Phase 34

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Randomized, Open-Label Study of the Bria-IMT Regimen and Check Point Inhibitor vs Physicians' Choice in Advanced Metastatic Breast Cancer.

RecruitingPH IIIBriaCell Therapeutics Corporationn=4042028

A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non-Small Cell Lung Cancer (POD1UM-304)

CompletedPH IIIIncyte Corporationn=5832026

A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy (POD1UM-303/InterAACT 2)

CompletedPH IIIIncyte Corporationn=3082025

A Phase 2/3 Trial to Evaluate Margetuximab in Combination With INCMGA00012 and Chemotherapy or MGD013 and Chemotherapy in Patients With Metastatic or Locally Advanced, Treatment-naïve, HER2-Positive Gastric or Gastroesophageal Junction Cancer

CompletedPH II/IIIMacroGenicsn=822025

A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of INCMGA00012, an Anti-PD-1 Antibody, in Combination With Chemoradiation in Participants With Unresectable, Stage III Non-Small Cell Lung Cancer (POD1UM-301)

WithdrawnPH IIIIncyte Corporation2025

Recent completions

Trials that read out recently, adding to the completed evidence base.

An Umbrella Study of INCMGA00012 Alone and in Combination With Other Therapies in Participants With Advanced or Metastatic Endometrial Cancer Who Have Progressed on or After Platinum-Based Chemotherapy (POD1UM-204)

CompletedPH IIIncyte Corporationn=2062026

A Randomized, Double Blind, Phase 3 Study of Platinum-Based Chemotherapy With or Without INCMGA00012 in First-Line Metastatic Squamous and Nonsquamous Non-Small Cell Lung Cancer (POD1UM-304)

CompletedPH IIIIncyte Corporationn=5832026

A Phase I/II Study of the SV-BR-1-GM Regimen in Metastatic or Locally Recurrent Breast Cancer Patients in Combination With Retifanlimab

CompletedPH I/IIBriaCell Therapeutics Corporationn=362026

Safety and Efficacy Study of Retifanlimab and Epacadostat in Combination With Radiation and Bevacizumab in Patients With Recurrent Gliomas

CompletedPH IIWashington University School of Medicinen=512025

A Phase 3 Global, Multicenter, Double-Blind Randomized Study of Carboplatin-Paclitaxel With INCMGA00012 or Placebo in Participants With Inoperable Locally Recurrent or Metastatic Squamous Cell Carcinoma of the Anal Canal Not Previously Treated With Systemic Chemotherapy (POD1UM-303/InterAACT 2)

CompletedPH IIIIncyte Corporationn=3082025

A Phase 1 Trial of Combined MEK, STAT3 and PD-1 Inhibition in Metastatic Pancreatic Ductal Adenocarcinoma

CompletedPH IPeter Hosein, MDn=282025

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Major research themes2
Carcinoma, Squamous Cell1Platinum1
Journals, researchers & institutions
Top journals
  • ESMO open1
Leading researchers
  • Anandappa G1
  • Arnold D1
  • Capdevila J1
  • Catlett M1
  • Cornfeld M1
  • Dahan L1
  • Demols A1
  • Evesque L1
Leading institutions
free-text, unnormalised
  • Aarhus University Hospital1
  • APHP-Sorbonne University-IUC1
  • AUSL Romagna Oncology Unit Faenza Hospital (RA)1
  • Centre Antoine Lacassagne1
  • Centre Hospitalier Régional Universitaire de Besançon1
  • City of Hope Comprehensive Cancer Center1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.