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To REMS Or Not To REMS? Erivedge Shows Division At FDA Over Oncology Risk Management

 
• By Sue Sutter

The review division and CDER senior staff supported approval of Genentech’s highly teratogenic, basal cell carcinoma treatment vismodegib without a Risk Evaluation and Mitigation Strategy, but the Division of Risk Management believed a communications plan should be carried out under a REMS for the first-in-class Hedgehog pathway inhibitor.

FDA’s largely hands-off approach to Risk Evaluation and Mitigation Strategies for oncology drugs was called into question during the NDA review of Genentech Inc.’s basal cell carcinoma treatment Erivedge (vismodegib). Although the policy withstood a challenge from the Center for Drug Evaluation and Research’s own internal risk management experts, the experience could spark a re-evaluation of the use, or rather non-use, of REMS for cancer drugs.

The oncology drug review division and CDER senior staff did not believe a REMS was necessary for vismodegib, which is...

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