1. Pink Sheet

US FDA’s ‘Project Optimus’ Will Encourage Move Away From Conventional Dose-Finding For Modern Cancer Therapies

 
• By Kate Rawson

Simply carrying forward the maximum tolerated dose into later-stage trials does not account for the importance of long-term tolerability – and the fact that higher doses are not necessarily better for patients.

"Optimus Prime" sits in the staging area during Transformers 3 filming on Wacker Drive in Chicago, Illinois on AUG 01, 2010. (Photo By Raymond Boyd/Michael Ochs Archives/Getty Images)
FDA's prepares to take the wheel and transform oncology dosing. • Source: Raymond Boyd/Michael Ochs Archives/Getty Images

The Oncology Center of Excellence’s latest “project” under development will investigate strategies for better dose optimization of oncology products and how to best implement them, US Food & Drug Administration Office of Oncologic Diseases medical oncologist Mirat Shah said during a “hot topics” in cancer regulation panel discussion at the American Association for Cancer Research annual meeting on 20 May.

While Shah did not give any specifics on “Project Optimus” itself, promising “there will be more to come,” she did outline what a better dose optimization program would look like....

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Approval Standards

More from Pathways & Standards

UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.

Life After Loper: Vaping Case Shows US FDA Retains Considerable Deference

 
• By Craig Bleifer, Royce DuBiner, Max Bogost, Michael Brody, and Allyson Maur

A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.