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FDA OKs Genentech's Perjeta: breast cancer benefit outweighs manufacturing risks
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Monday, June 18, 2012
Facing eleventh-hour manufacturing problems of a sort that can
easily derail a drug, Genentech
Inc. worked with FDA to devise a plan that enabled the agency to grant
full approval for Perjeta pertuzumab for first-line HER2-positive metastatic
breast cancer without a delay.
FDA was able to take the
unusual step of approving a drug whose manufacturing process is not assured in
part because of the availability of an undisclosed amount of the drug
manufactured before the problems began, and because of a postmarketing plan
detailing steps Genentech will take to resume and validate Perjeta
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