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.
- 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
- IncyteCARES
- PAN Foundation — Disease-specific co-pay and premium funds; open and closed funds change monthly.
- HealthWell Foundation
- CancerCare Co-Payment Assistance Foundation
- Patient Advocate Foundation Co-Pay Relief
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.
- 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.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2023 | Metastatic or recurrent locally advanced Merkel cell carcinoma |
| US | 2025 | Locally recurrent or metastatic anal SCC with carboplatin-paclitaxel; monotherapy after platinum |
| EU | 2024 | Merkel cell carcinoma |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Latest papers
topQuery 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.
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