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Genentech’s Perjeta Clears FDA Despite Unresolved Manufacturing Issues

Executive Summary

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.

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