> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Checkpoint Resubmits Cosibelimab BLA
- URL: https://www.fdaweb.com/checkpoint-resubmits-cosibelimab-bla/
- Published: 2024-07-08T12:00:00.000Z
- Updated: 2026-09-14T14:34:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157293

Checkpoint Therapeutics says it has completed the resubmission of its BLA to FDA for cosibelimab, an anti-programmed death ligand-1 antibody as a potential new treatment for patients with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or radiation. A company [statement](https://ir.checkpointtx.com/news-events/press-releases/detail/119/checkpoint-therapeutics-announces-biologics-license?ref=fdaweb.com) says the resubmission follows an agreement reached with FDA on a strategy to potentially address all approvability deficiencies outlined in a 12/2023 complete response letter. The company says the letter only cited findings that arose during a multi-sponsor inspection of Checkpoint’s third-party contract manufacturing organization and did not state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab.