FDA CRL - Checkpoint Therapeutics, Incorporated

The FDA issued a Complete Response Letter (CRL) to Checkpoint Therapeutics, Incorporated, regarding its Biologics License Application (BLA) for cosibelimab (CK-301) under section 351(a) of the Public Health Service Act. The primary reason for non-approval stems from unresolved deficiencies identified during a pre-license inspection of Samsung Biologics Co., Ltd., Incheon, Korea, the designated manufacturing facility for drug substance and drug product. The FDA found that not all deficiencies were satisfactorily resolved, leading to concerns about the reliability of data generated at this facility. This impacts the data supporting manufacturing process validation and characterization, preventing the determination of the proposed manufacturing process's adequacy and overall control strategy. Checkpoint Therapeutics must ensure Samsung Biologics provides satisfactory responses to these deficiencies and include this information in their complete response. If data is removed or the control strategy modified, reliable new data must be provided. Additional requirements include submitting a comprehensive safety update, resubmitting the proposed proprietary name "Unloxcyt," and addressing comments on prescribing, carton, container, and medication guide labeling. The company has one year to resubmit or take other actions.