On Friday, the FDA approved Checkpoint Therapeutics, Inc.'s (NASDAQ:CKPT) Unloxcyt (cosibelimab-ipdl) for metastatic cutaneous squamous cell carcinoma (cSCC) or locally advanced cSCC who are not candidates for curative surgery or curative radiation.
Unloxcyt is the first and only programmed death ligand-1 (PD-L1) blocking antibody to receive FDA marketing approval for this indication.
The recommended commercial dosage of Unloxcyt is 1,200 mg administered as an intravenous infusion over 60 minutes every three weeks.
The FDA approval comes ahead of its PDUFA date of December 28.
"Today's FDA approval of Unloxcyt – the first marketing approval for our company...This approval marks Checkpoint's transformation to a commercial-stage company, with the opportunity to compete in a U.S. market estimated to exceed $1 billion annually, where we believe Unloxcyt offers a differentiated treatment option versus available therapies," said James Oliviero, President and Chief Executive Officer of Checkpoint.
Cutaneous squamous cell carcinoma is the second most common type of skin cancer in the U.S., with an estimated annual incidence of approximately 1.8 million cases, according to the Skin Cancer Foundation.
While most cases are localized tumors amenable to curative resection, each year, approximately 40,000 cases become advanced, and an estimated 15,000 people in the U.S. die from this disease.
FDA approval for Unloxcyt was granted based on clinically meaningful objective response rates and duration of response data, as assessed by an independent central review committee from Study CK-301-101.
Last year, Checkpoint Therapeutics received a complete response letter (CRL) regarding their application for cosibelimab.
The letter pointed out issues related to a third-party manufacturer's inspection, not concerns about the treatment's effectiveness or safety.
Price Action: CKPT stock is up 3.54% at $3.80 during the premarket session at last check Monday.
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