cosibelimab

FDA Drug Profile — UNLOXCYT

cosibelimab is listed in the FDA National Drug Code directory with 3 NDC codes, marketed under brand name including UNLOXCYT. Available dosage forms: injection, injection, solution, liquid.

Drug Details

Generic Name
cosibelimab
Brand Names
UNLOXCYT
Application Number
BLA761297
Sponsor
Samsung BioLogics Co. LTD
NDC Codes
3
Dosage Forms
INJECTION, INJECTION, SOLUTION, LIQUID
Routes
INTRAVENOUS
Active Ingredients
COSIBELIMAB-IPDL, COSIBELIMAB

Indications and Usage

1. INDICATIONS AND USAGE UNLOXCYT is indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation. UNLOXCYT is a programmed death ligand-1 (PD-L1) blocking antibody indicated for the treatment of adults with metastatic cutaneous squamous cell carcinoma (mCSCC) or locally advanced CSCC (laCSCC) who are not candidates for curative surgery or curative radiation.