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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.

Stop barrier

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 possibly

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• By Francesca Bruce

EU-level joint clinical assessments conducted under the Health Technology Assessment Regulation need to be more flexible when it comes to evidence requirements, according to experts speaking at a gene and cell therapy conference.

EU ‘Can’t Expect Industry To Give Up Proprietary Insights’ Under Health Data & Clinical Trials Regulations

 
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Both the EU Clinical Trials Regulation and the European Health Data Space Regulation have the potential to improve harmonization and be highly valuable for industry – but the importance of protecting company data will be paramount, a life sciences consultant says.

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