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Posted On: 12/19/2023 9:15:11 PM
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From CKPT:
U.S. Food and Drug Administration Issues Complete Response Letter for Cosibelimab Solely Due to Inspection Findings at Third-Party Manufacturer
December 18, 2023 7:00am EST
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FDA did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab
WALTHAM, Mass., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), today announced that the U.S. Food and Drug Administration (“FDA”) has issued a complete response letter (“CRL”) for the cosibelimab biologic license application (“BLA”) for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma (“cSCC”) who are not candidates for curative surgery or radiation. The CRL only cites findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization as approvability issues to address in a resubmission.
The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab.
“As the only deficiencies relate to the FDA’s inspection of our third-party contract manufacturing organization, we believe we can address the feedback in a resubmission to enable marketing approval in 2024,” said James Oliviero, President and Chief Executive Officer of Checkpoint. “We are committed to working closely with our third-party manufacturer and the FDA on our resubmission in order to make cosibelimab available to patients living with cSCC.”
U.S. Food and Drug Administration Issues Complete Response Letter for Cosibelimab Solely Due to Inspection Findings at Third-Party Manufacturer
December 18, 2023 7:00am EST
Download as PDF
FDA did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab
WALTHAM, Mass., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Checkpoint Therapeutics, Inc. (“Checkpoint”) (Nasdaq: CKPT), today announced that the U.S. Food and Drug Administration (“FDA”) has issued a complete response letter (“CRL”) for the cosibelimab biologic license application (“BLA”) for the treatment of patients with metastatic or locally advanced cutaneous squamous cell carcinoma (“cSCC”) who are not candidates for curative surgery or radiation. The CRL only cites findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization as approvability issues to address in a resubmission.
The CRL did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab.
“As the only deficiencies relate to the FDA’s inspection of our third-party contract manufacturing organization, we believe we can address the feedback in a resubmission to enable marketing approval in 2024,” said James Oliviero, President and Chief Executive Officer of Checkpoint. “We are committed to working closely with our third-party manufacturer and the FDA on our resubmission in order to make cosibelimab available to patients living with cSCC.”
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