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Master Protocols In Practice

 
• By Bridget Silverman

Basket trials are building a path for tissue-agnostic drug development in oncology, and plans are proceeding for more master protocols in pediatric cancers, acute myeloid leukemia and pancreatic cancer.

Master protocol trial designs are slowly gaining ground, especially in oncology development, as results have emerged from the early generation of basket and umbrella trials.

Basket trial data was crucial to the approval of FDA's first tissue-agnostic oncology indication on May 23, 2017, when Merck & Co. Inc. 's Keytruda (pembrolizumab) received accelerated approval for patients defined by a biomarker (microsatellite instability-high or mismatch repair deficient cancers) rather than a tumor's anatomical location of origin

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