Core Insights - Checkpoint Therapeutics has received FDA approval for UNLOXCYT (cosibelimab-ipdl), the first and only PD-L1 blocking antibody for advanced cutaneous squamous cell carcinoma (cSCC) [1][3] - The approval signifies Checkpoint's transition to a commercial-stage company, with a market opportunity exceeding $1 billion annually in the U.S. [3] - UNLOXCYT offers a differentiated treatment option by binding to PD-L1, potentially inducing antibody-dependent cell-mediated cytotoxicity (ADCC) [3][7] Company Overview - Checkpoint Therapeutics is focused on developing and commercializing novel treatments for solid tumor cancers [26] - The company is headquartered in Waltham, MA, and was founded by Fortress Biotech, Inc. [27] Product Details - UNLOXCYT is indicated for adults with metastatic or locally advanced cSCC who are not candidates for curative surgery or radiation [8] - The recommended dosage is 1,200 mg administered intravenously every three weeks [2] Market Context - cSCC is the second most common skin cancer in the U.S., with an estimated annual incidence of approximately 1.8 million cases [5] - About 40,000 cases of cSCC become advanced each year, leading to approximately 15,000 deaths annually in the U.S. [5] Clinical Significance - UNLOXCYT has demonstrated clinically meaningful objective response rates and durable responses in advanced cSCC [3] - The drug's dual mechanisms of action and safety profile provide oncologists with a new immunotherapy option [3] Future Plans - Checkpoint is developing a commercial launch plan for UNLOXCYT following its FDA approval [4]
Checkpoint Therapeutics Announces FDA Approval of UNLOXCYT™ (cosibelimab-ipdl)