Treats inoperable locally recurrent or metastatic squamous cell carcinoma of the anal…. Sold as Zynyz. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Retifanlimab-Dlwr (sold as Zynyz), first approved Mar 22, 2023, with 4 new uses approved and 0 published complete response letters.
| Zynyz | Part B | $14.4M | +1280% | 276 |
| Zynyz | Part D | $386K | New | 11 |
| NIMBLE-CRC: NeoImmunoModulation Before Leveraging Excision in Colorectal Rectal CancerColon Cancer Metastatic · Northwell Health | Phase 2 | Not yet recruiting | Jul 1, 2026 |
| ASTX727 & Retifanlimab-dlwr for Advanced Merkel Cell After Progression on Anti-PD-(L)1Merkel Cell Carcinoma, Merkel Cell Carcinoma, Stage III · University of Wisconsin, Madison | Phase 1 / Phase 2 | Not yet recruiting | Mar 16, 2026 |
| Retifanlimab With or Without Difluoromethylornithine for the Treatment of Progressive High Grade GliomasAnaplastic Oligodendroglioma, Astrocytoma, IDH-Mutant, Grade 3 · Mayo Clinic | Phase 1 / Phase 2 | Recruiting | Mar 12, 2026 |
| Axatilimab in Combination With Retifanlimab and Paclitaxel for the Treatment of Patients With Advanced or Metastatic Solid TumorsAdvanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm · OHSU Knight Cancer Institute | Phase 1 / Phase 2 | Recruiting | Mar 20, 2024 |
| Retifanlimab with Bevacizumab and Hypofractionated Radiotherapy for the Treatment of Recurrent GlioblastomaRecurrent Glioblastoma, Recurrent WHO Grade 4 Glioma · Academic and Community Cancer Research United | Phase 2 | Recruiting | Dec 7, 2023 |
| Triple Immune Checkpoint Inhibition for Advanced or Metastatic PD-(L)1 Refractory Merkel Cell CarcinomaUnresectable Clinical Stage III Merkel Cell Carcinoma AJCC v8, Clinical Stage IV Merkel Cell Carcinoma AJCC v8 · University of Washington | Phase 2 | Active, not recruiting | Sep 28, 2023 |
| Tafasitamab, Retifanlimab, and Rituximab in Combination With Standard Therapy for the Treatment of Diffuse Large B-cell LymphomaDiffuse Large B-Cell Lymphoma, Grade 3b Follicular Lymphoma · University of Washington | Phase 1 / Phase 2 | Active, not recruiting | Jul 13, 2022 |
| Short-term Fasting Prior to PD-1/PD-L1 Inhibitor Therapy for of Advanced or Metastatic Skin MalignancyAdvanced Malignant Skin Neoplasm, Metastatic Malignant Skin Neoplasm · University of Southern California | Phase 1 | Active, not recruiting | May 13, 2020 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Mar 22, 2023 | ZynyzBLA 761334 · New molecular entity | Incyte Corp | 5 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
