Surrogate Endpoints Only Have ‘Limited’ Evidence On Cancer Survival, Review Concludes
This article was originally published in The Pink Sheet Daily
21st Century Cures legislation also criticized in JAMA Internal Medicine editorial.
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Approval of Pfizer's breast cancer therapy palbociclib on the basis of Phase II data required an exhaustive set of statistical sensitivity analyses and a striking number of pre-NDA meetings.
CDER’s Woodcock says accelerated approval requirements in 21st Century Cures legislation could create a process akin to how FDA handles breakthrough designations.
FDA Commissioner Margaret Hamburg says Genentech has failed to identify a subpopulation of patients in whom the clinical benefits outweigh the risks. The company says it will not appeal the indication’s withdrawal but will pursue a new study in breast cancer.