Biomarkers Consortium Launches Adaptive Trial To Test Targeted Breast Cancer Drugs
This article was originally published in The Pink Sheet Daily
The five-year I-SPY 2 study is a model for drug development and an innovative screening process for identifying winners, FDA's Woodcock says.
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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 protocols that allow for the simultaneous study of multiple agents will shave more time off in the clinic than one-off studies in small groups of patients, FDA’s Janet Woodcock predicted. The current timeframes in oncology development are “unacceptable,” and can be shortened, she said, by “doing things differently.”
Sponsors say the large number of biomarkers that will be searched for in candidates for the lung cancer trial should allow researchers to find patients much faster, and will offer cost-savings over traditional drug development.