BLA submitted to FDA for Cosibelimab as a Treatment for Patients with Metastatic or Locally Advanced Cutaneous Squamous Cell Carcinoma
“This is a major milestone for Checkpoint Therapeutics, representing our first submission of a marketing application for one of our investigational medications and furthering our evolution from a development-stage company to a fully integrated commercial organization to support the potential launch of cosibelimab,” said James Oliviero, President and Chief Executive Officer of Checkpoint. “cSCC is the second most common type of skin cancer in the United States. While most cases involve localized tumors amenable to curative resection, approximately 40,000 cases will become advanced, and an estimated 15,000 people will die from their disease each year. Based on its compelling and differentiated product profile and the positive data generated to date, we believe cosibelimab has the potential to be an important treatment option for patients. Importantly, we continue to plan for cosibelimab to be positioned, upon regulatory approval, as potentially the first and only price disruptive PD-1/PD-L1 inhibitor in the U.S. market.” Mr. Oliviero continued, “We want to thank the patients and their families, as well as the physicians and their research teams, who participated in our trial and contributed immensely to the advancement of cosibelimab.”
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