FDA Approves UNLOXCYT for Advanced Cutaneous Squamous Cell Carcinoma, Marking a New Era in Skin Cancer Treatment

FDA Approval:
The U.S. Food and Drug Administration (FDA) has approved UNLOXCYT (cosibelimab-ipdl) for the treatment of adults with metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or curative radiation13.

First and Only:
UNLOXCYT is the first and only FDA-approved anti-PD-L1 treatment for advanced cSCC, offering a differentiated treatment option by binding to PD-L1 and inducing antibody-dependent cell-mediated cytotoxicity (ADCC)1.

Clinical Significance:
The approval was based on clinically meaningful objective response rates and duration of response data from Study CK-301-101, highlighting UNLOXCYT's potential to provide durable responses in advanced cSCC patients1.

Market Impact:
The approval marks Checkpoint Therapeutics' transformation to a commercial-stage company, with the opportunity to compete in a U.S. market estimated to exceed $1 billion annually1.

Commercial Launch:
Checkpoint Therapeutics is currently developing a commercial launch plan for UNLOXCYT and seeks a partner for the launch3.

Sources:

1. https://ir.checkpointtx.com/news-events/press-releases/detail/127/checkpoint-therapeutics-announces-fda-approval-of

3. https://endpts.com/checkpoint-wins-fda-approval-of-checkpoint-inhibitor-in-advanced-skin-cancer-seeks-partner-for-launch/