Checkpoint Therapeutics Announces Alignment with FDA Enabling Upcoming Cosibelimab BLA Resubmission [Yahoo! Finance]
Fortress Biotech, Inc. (FBIO)
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Source: Yahoo! Finance
targeted oncology company, today announced it has reached alignment with the Food and Drug Administration (“FDA”) on its biologics license application (“BLA”) resubmission strategy for cosibelimab. Accordingly, Checkpoint plans to move forward with a mid-year BLA resubmission seeking the U.S. marketing approval for cosibelimab as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma (“cSCC”) who are not candidates for curative surgery or curative radiation. James F. Oliviero, President and Chief Executive Officer of Checkpoint, said, “We're pleased to have reached alignment with the FDA on our BLA resubmission strategy to potentially address all approvability deficiencies outlined in the complete response letter (“CRL”) received last December. We're eager to resubmit our BLA and to potentially bring a new and potentially differentiated immunotherapy treatment option to patients with advanced cSCC.” In December 2023, the FDA is
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