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Keytruda: US FDA Reflects On Lessons Learned From Failed Myeloma Studies

 
• By Sue Sutter

Importance of randomized, controlled trials and need for a thoughtful, considered approach to development of rational combinations are highlighted by the increased mortality risk seen with pembrolizumab treatment in two halted multiple myeloma studies, FDA officials say.

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The troubling mortality results from two multiple myeloma trials of Merck & Co. Inc.'s PD-1 inhibitor Keytruda (pembrolizumab) suggest important lessons for future immunotherapy studies of combination regimens, US FDA officials say.

The higher rate of death in the pembrolizumab-containing arms in both the KEYNOTE-183 and KEYNOTE-185 studies underscores the importance of randomized, controlled trials and the need for sponsors to consider...

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US FDA’s Prasad: ‘We Will Always Embrace Surrogate Endpoints’

 
• By Sarah Karlin-Smith

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UK And US Regulators In Sync On RWD External Control Arms

 
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The UK regulator’s draft guideline on the use of external control arms based on real-world data reflects concepts similar to those outlined by the US Food and Drug Administration.

EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

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EU To Track Decentralized Clinical Trials In CTIS To Support Innovation

 
• By Vibha Sharma

Monitoring the use of decentralized elements in clinical trials is a priority for the European medicines regulatory network.

Pink Sheet Podcast: US FDA’s Big Vaccine Policy Week

 
• By Derrick Gingery, Sarah Karlin-Smith, Sue Sutter, and Nielsen Hobbs

Pink Sheet reporter and editors discuss the new clinical trial requirements that the FDA announced for COVID-19 vaccines, the updated label for Novavax’s newly approved COVID-19 vaccine, and other vaccine-related events that were part of a busy week for policy in the sector.

ICH Targets RWE, Rare Diseases, Biosimilars, ATMPs In New Guideline Push

 
• By Vibha Sharma

The International Council for Harmonisation has identified four new topics that can benefit from global regulatory alignment, with timelines for initiating work to be determined later.