Skip to main content

Zynyz FDA Approval History

Last updated by Judith Stewart, BPharm on May 20, 2025.

FDA Approved: Yes (First approved March 22, 2023)
Brand name: Zynyz
Generic name: retifanlimab-dlwr
Dosage form: Injection
Company: Incyte Corporation
Treatment for: Anal Cancer, Merkel Cell Carcinoma

Zynyz (retifanlimab-dlwr) is a programmed death receptor-1 (PD-1)-blocking antibody used for the treatment of advanced anal cancer and Merkel cell carcinoma.

Development timeline for Zynyz

DateArticle
May 15, 2025Approval Incyte Announces FDA Approval of Zynyz (retifanlimab-dlwr) Making it the First and Only Approved First-Line Treatment for Advanced Anal Cancer Patients in the United States
Mar 22, 2023Approval FDA Approves Zynyz (retifanlimab-dlwr) for the Treatment of Metastatic or Recurrent Locally Advanced Merkel Cell Carcinoma (MCC)
Jul 23, 2021Incyte Provides Regulatory Update on Retifanlimab for the Treatment of Certain Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)
Jan 21, 2021Incyte Announces Acceptance and Priority Review of BLA for Retifanlimab as a Potential Treatment for Patients with Squamous Cell Carcinoma of the Anal Canal (SCAC)
Sep 18, 2020Incyte Announces Encouraging Results From Phase 2 Trial of Retifanlimab (INCMGA0012) in Patients With Previously Treated, Advanced Squamous Cell Carcinoma of the Anal Canal

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.