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No Excuses: US FDA Wants Early, Thorough Dosage Optimization For Cancer Drugs

Executive Summary

Breakthrough therapy designation is not a sufficient reason to avoid identifying an optimal dosage prior to submitting a marketing application, agency says in draft guidance under Project Optimus. Guidelines also emphasize randomized comparisons of multiple dosages and exploration of tolerability issues.

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Confirmatory Trials: Comprehensive Development Plan, Early Communication Will Help Reduce Delays, US FDA Says

Accelerated approval sponsors who want to demonstrate due diligence in conducting confirmatory trials should bring a comprehensive program for verifying benefit to the agency early and be proactive in communicating about challenges that could lead to delays, FDA’s oncology review staff say at an adcomm on delayed trials for Acrotech’s lymphoma drugs.

Premarket Dose Optimization Precedent In Oncology Likely Not Available Yet

The current crop of cancer drug approvals were well along in development when Project Optimus launched, meaning they may not have been able to implement the Oncology Center of Excellence’s premarket dose optimization policy.

Project Optimus Is Coming To Cancer Combination Therapy Development

FDA initiative aimed at optimizing cancer drug dosage earlier in development started with single-agent therapies, but moving into combinations is ‘a natural progression,’ Oncology Center of Excellence’s Richard Pazdur says. At a recent workshop, experts discuss considerations for combination product dosage optimization and review case studies that reflect Optimus principles.

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