Daiichi Sankyo, Inc. – FDA CRL

The U.S. Food & Drug Administration issued a Complete Response Letter to Daiichi Sankyo, Inc., indicating that their Biologics License Application (BLA 761366) for HER3-Dxd is not approvable in its current form. A primary concern is unresolved deficiencies identified during a pre-license inspection of a manufacturing facility. Daiichi Sankyo must provide satisfactory responses to these inspection findings and include this information in their resubmission.

Furthermore, the FDA requires a comprehensive safety update. This involves integrating all new nonclinical and clinical study data, detailing any significant changes to the safety profile, providing updated adverse event tabulations, submitting case report forms for serious adverse events or deaths, and summarizing global safety experience. While the proposed proprietary name was conditionally acceptable, it must be resubmitted with the complete application. Labeling comments are reserved, but specific instructions were provided regarding the Medication Guide statement.

Daiichi Sankyo is required to address all deficiencies fully within one year, clearly labeling their submission as a "RESUBMISSION." The FDA also noted that a proposed confirmatory study did not meet its pre-specified efficacy boundary and recommended a meeting to discuss alternative clinical trial strategies.