Zynyz (retifanlimab-dlwr)

BL 761334

Zynyz (retifanlimab-dlwr)

BL 761334

U.S. License Holder:

Incyte Corp.

Date of License:

March-22-2023

Last Update:

June-15-2025

approved_indications FDA-Approved Indications

ZYNYZ (retifanlimab-dlwr) is a programmed death receptor-1 (PD-1)-blocking antibody indicated:

Squamous Cell Carcinoma of the Anal Canal (SCAC): In combination with carboplatin and paclitaxel for the first-line treatment of adult patients with inoperable locally recurrent or metastatic squamous cell carcinoma of the anal canal (SCAC); As a single agent for the treatment of adult patients with locally recurrent or metastatic SCAC with disease progression on or intolerance to platinum-based chemotherapy;

Merkel Cell Carcinoma (MCC): For the treatment of adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma.

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Methodology

Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.

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