ZYNYZ retifanlimab

Drug Class

PD-1 antagonist monoclonal antibody

Mechanism

Binds to PD-1 on immune cells, preventing ligand binding (PD-L1 and PD-L2) and restoring T-cell activation and proliferation.

Approved Indication

Metastatic or recurrent locally advanced Merkel cell carcinoma, per its FDA approval.

What This Means For Patients

Zynyz is a targeted immunotherapy designed to treat patients with Merkel cell carcinoma, a rare and aggressive form of skin cancer. By blocking the PD-1 checkpoint pathway, it enables the immune system to recognize and attack cancer cells, and is available in Hainan Lecheng.

Regulatory Approvals

• FDA — approved (2023) — label

Pivotal Clinical Evidence

• POD1UM-201 — Grignani et al., J Immunother Cancer 2025 (NCT03599713) — DOI

Sources

• https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-retifanlimab-dlwr-merkel-cell-carcinoma
• https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761304s000lbl.pdf