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Lessons From Avastin: Accelerated Approval Needs “Easy On, Easy Off” Mechanism, Pazdur Says

 
• By Sue Sutter

FDA’s oncology office director says the resource-intensive hearing process for withdrawing bevacizumab’s breast cancer claim demonstrates that it is “untenable for a large number of drugs.”

Any reforms aimed at making it easier for drug sponsors to pursue accelerated approval should be accompanied by changes that make it easier for FDA to withdraw drugs when post-approval trials fail to confirm clinical benefit, Office of Hematology and Oncology Products Director Richard Pazdur said at the Conference on Clinical Cancer Research Nov. 14.

Speaking from the audience during a panel discussion on ways to expand the use of accelerated approval, Pazdur said FDA’s experience in withdrawing Avastin’s (bevacizumab) breast cancer claim makes clear...

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More from United States

Scientists Work With AI To Uncover ‘Unexpected’ Drug Combos for Breast Cancer

 
• By Natasha Barrow

A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.

Saving Part D: US Medicare Advisors Sound The Alarm

 
• By Michael McCaughan

The US Medicare Patient Advisory Commission worries that Medicare prescription drug market trends may cause the stand-alone plan portion of the program to “wither away,” which could take the traditional fee-for-service side of Medicare with it.

Clinical Trials Nonprofit Fights for Access Despite DEI Crack-Down

 
• By Sue Sutter

The Clinical Trials Access Collaborative (CTAC) will build on a pilot program's work to bolster community-based clinical research infrastructure so "anyone who wants to participate in clinical trials can and do it closer to home,” CEO Tesheia Harris said in an interview.

US FDA Cell-Gene Therapy Head Says Agency Has Revived Stalled Programs

 
• By Sarah Karlin-Smith

CBER's Nicole Verdun wants rare disease sponsors with stalled treatments to circle back because the FDA's evolved thinking on clinical trial designs may offer another opportunity for cast away products.

More from North America

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

User Fee-Funded Staff Would Drop In FY 2026 US FDA Budget

 
• By Derrick Gingery

The reductions across medical product programs in the agency’s budget request include hundreds of positions funded by user fees, which may foreshadow its upcoming user fee restructuring strategy.

Canada Cuts Red Tape With Single Ethics Review For Trials

 
• By Neena Brizmohun

A new research ethics review system for multi-site clinical trials in Canada is expected to help improve study start-up times, avoid unnecessary duplication and boost the country’s competitiveness on a global stage.