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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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More from United States

US FDA Teases Disclosure Program, But Industry Has Seen This Before

 
• By Derrick Gingery

Center for Biologics Evaluation and Research Director Vinay Prasad said Commissioner Martin Makary wants to release previously inaccessible FDA documents, but previous commissioners have made the same pronouncements only to make little progress.

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• By Sue Sutter

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• By Bridget Silverman

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Pink Sheet Podcast: The US and Ex-US Impact Of Most-Favored Nation Drug Pricing

 
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Pink Sheet reporter and editors discuss the potential impact of the Most-Favored Nation drug pricing proposal on Europe, the United States, as well as the pharmaceutical industry.

More from North America

Recent And Upcoming FDA Advisory Committee Meetings

 
• By Sue Sutter

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US FDA Could Miss User Fee Spending Triggers With House FY 2026 Funding

 
• By Sarah Karlin-Smith and Derrick Gingery

FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

PCMA, CVS, Cigna File Lawsuits Over ‘Dangerous’ Arkansas PBM Law

 
• By Tim Casey

The suits are an early test of the Arkansas law banning company ownership of PBMs and pharmacies in the state, as other states consider similar legislation.