Immunomedics Dodges Manufacturing Site Specifics In Quest For Cancer Breakthrough Approval

 
• By Bowman Cox
  
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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.

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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...

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