Drug · Monoclonal Antibody
Retifanlimab
CI-DRUG-00000766Explore in graph →CHEMBL4298037 Approved
Regulatory
Approvals (8)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- Health Canada — Drug Product Database (DPD)
- Dataset
- Health Canada DPD
- Version
- dpd-2026-09-11
- Retrieved
- Sep 11, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- Open Government Licence – Canada (https://open.canada.ca/en/open-government-licence-canada)
- Run
- ING-HEALTHCANADADPD-20260911-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| CA Health Canada | — | Marketed in Canada as ZYNYZ (DIN 02555239) under ATC L01FF10 RETIFANLIMAB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph. | approvedsource: Marketed | Aug 14, 2025 | health-canada-dpd |
| EU EMA | Merkel Cell Carcinoma | 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. | approved | Apr 19, 2024 | ema |
| US FDA | — | Efficacy supplement 2026-05-18 (see label) | approved | May 18, 2026 | openfda |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 19 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 3 | 30 | 16 | 6 | 64 | 8 | CA, EU, US | Mar 22, 2023 | Feb 27, 2015 |
| Malignant Breast Neoplasm | Phase3 | Phase 3 | 3 | 2 | 1 | 6 | 0 | — | — | Feb 27, 2015 |
| Malignant Gastric Neoplasm | Phase3 | Phase 3 | 1 | 1 | 1 | 3 | 0 | — | — | Feb 27, 2015 |
| Malignant Lung Neoplasm | Phase3 | Phase 3 | 1 | 1 | 1 | 6 | 0 |
Curated evidence
Clinical evidence (0)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
Data not yet available
Clinical trials
Trials with this intervention (65)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT06149481 | 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) | recruiting | Phase 1 / Phase 2 | 60 | National Cancer Institute (NCI)NIH | 1 | Sep 28, 2026 | clinicaltrials |
| NCT04472429 | Carboplatin-paclitaxel With Retifanlimab or Placebo in Participants With Locally Advanced or Metastatic Squamous Cell Anal Carcinoma (POD1UM-303/InterAACT 2). |