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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...

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More from Clinical Trials

Industry Groups Back EU Life Sciences Strategy As Commission Pledges Clinical Trial Investment

 
• By Eliza Slawther

Industry associations EFPIA, EUCOPE and EURORDIS have praised the European Commission’s newly launched life sciences strategy, which will see investment funnelled into improving the clinical trial ecosystem and supporting advanced therapy development.

Pharma Companies Suspecting Clinical Trial Fraud Should Move Quickly, Quietly

 
• By Sue Sutter

Sponsors should investigate signals of possible fraud in a manner that does not raise alarms or else evidence might disappear, UK and US regulators said.

Swissmedic Launches Pilot To Expedite Clinical Trial Applications

 
• By Anabel Costa-Ferreira

Swiss health care products agency Swissmedic will launch a pilot in July to fast track clinical trial applications, which the agency claims will place Switzerland at the forefront compared to other European countries.

EU Countries Rally Behind Novel Pathway For Combined Drug/IVD Trials

 
• By Vibha Sharma

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

More from R&D

EU Countries Rally Behind Novel Pathway For Combined Drug/IVD Trials

 
• By Vibha Sharma

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.

New EFPIA President Hopes ‘Sanity Will Prevail’ In EU Pharma Reform Dialogs

 
• By Eliza Slawther

Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.

UK Pilots Faster Setup Of Early Phase Oncology Trials

 
• By Vibha Sharma

Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.