Immunomedics Dodges Manufacturing Site Specifics In Quest For Cancer Breakthrough Approval

Biotech firm chooses words carefully to wind its way through site inspection findings and CMC review concerns in hopes of winning its first FDA approval for a breakthrough breast cancer treatment.

Discretion

Immunomedics Inc. executives are avoiding drawing any connection between good manufacturing practice issues raised in a pre-license site inspection report of the firm’s Morris Plains, New Jersey, facility and the chemistry, manufacturing and controls issues raised in the agency’s complete response to the firm’s biologics license application for a breakthrough cancer therapy.

The US FDA granted the firm’s sacituzumab govitecan breakthrough therapy status for a narrow indication – third-line or greater treatment of patients with metastatic triple-negative breast cancer – and the antibody-drug conjugate has huge potential in

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