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Genentech’s Perjeta Clears FDA Despite Unresolved Manufacturing Issues

 
• By Sue Sutter

In approving for marketing a finite supply of pertuzumab, FDA determined that the benefit of making a new breast cancer treatment available outweighs the risk that the drug could go into shortage due to production problems. The manufacturing concerns led to a split within the agency on the question of approval, with CDER Director Woodcock making the final call.

FDA approved Genentech Inc.’s metastatic breast cancer treatment Perjeta (pertuzumab) June 8 despite uncertainties surrounding the company’s ability to manufacture and supply the biologic over an extended period of time.

Approval came down to a determination that the benefit of making available a new HER2-targeted breast cancer treatment outweighed the risk that the product would go into

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