OnCo
drugsProductNot mapped hereapproved

Retifanlimab

Retifanlimab is a PD-1 antibody approved for Merkel cell carcinoma and, with chemotherapy, as the first immunotherapy standard for advanced anal cancer.

POD1UM-201: 52% response in chemo-naive metastatic Merkel cell carcinoma (accelerated approval 2023). POD1UM-303/InterAACT-2 (Lancet 2025): adding retifanlimab to carboplatin-paclitaxel improved PFS and OS in first-line advanced anal SCC, leading to approval in 2025.

Schematic of the modality · Anti-PD-1 monoclonal antibody (IgG4) · not a molecule; see the Immune checkpoint inhibitors page
How it works, step by step · animated schematic, not to scale
Immune checkpoint inhibitors
Modality
Anti-PD-1 monoclonal antibody (IgG4)
Mechanism
Blocks PD-1 binding to PD-L1/PD-L2, restoring T-cell activity.
Brand / code
Zynyz
Medicare
Part B (clinician-administered)

Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. FDA-approved for Merkel cell carcinoma and squamous anal cancer.

Commercial insurance
covered with prior authorisation

Covered under the medical benefit with prior authorisation confirming diagnosis, biomarker status and line of therapy; site-of-care policies may steer infusions away from hospital outpatient departments.

Assistance programmes

20% Part B coinsurance on a high-cost infusion adds up quickly: Medigap Plan G or N, Medicare Advantage maximum out-of-pocket, Medicaid dual eligibility, or a charity fund are the usual buffers.

Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.

Not yet researchedSearch NICE
Notes
EU-licensed 2024 for Merkel cell carcinoma; UK licence and NICE position not yet researched.

Sources: NICE search: retifanlimab. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.

Regulatory

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Approvals

RegionYearIndication
US2023Metastatic or recurrent locally advanced Merkel cell carcinoma
US2025Locally recurrent or metastatic anal SCC with carboplatin-paclitaxel; monotherapy after platinum
EU2024Merkel cell carcinoma

Trials

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ClinicalTrials.gov · phase 2/3
refreshed 2026-09-09
43 studies12 recruiting39 Phase 25 Phase 3
Search “Retifanlimab” on ClinicalTrials.gov →
Counts are from a name search and may include unrelated studies; up to 100 studies are summarised.

Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Retifanlimab
intervention: Retifanlimab
Open on ClinicalTrials.gov →

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Latest papers

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Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Retifanlimab" OR ABSTRACT:"Retifanlimab" OR TITLE:"Zynyz" OR ABSTRACT:"Zynyz") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Retifanlimab, not a curated reading list.

Connected

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