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Project Optimus Is Coming To Cancer Combination Therapy Development

 
• By Sue Sutter

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.

Past and future
Under Project Optimus, future development programs for combination anti-cancer therapies may look different from those in the past. • Source: Shutterstock

The US Food and Drug Administration’s Project Optimus, which has changed how sponsors approach dosage optimization for single-agent oncology agents, is coming to combination therapies.

During a recent two-day workshop sponsored by the agency and American Society of Clinical Oncology, FDA officials made clear that sponsors should be prepared to apply the

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