FDA’s First “Breakthrough” Approval Coming; Won’t Break Speed Records
This article was originally published in RPM Report
Executive Summary
Genentech’s oncologic obinutuzumab is expected to be one of the first Breakthrough therapies approvals under PDUFA V. The data look game-changing for chronic lymphocytic leukemia patients. But will it result in a faster FDA review? Under the agency’s new review Program, probably not.
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