Staats H, Cassidy C, Kelso J, Mack S, Morand S, Choucair K, Qaqish H, Willis O, Craig D, Duff J, Stanbery L, Edelman G, Dworkin L and Nemunaitis J
Acknowledging the correlation of response to therapy based on the “targeting the target” concept, FDA demonstrated confidence in precision therapy approaches by approving Foundation One® CDx test in late 2017 as an indicated diagnostic for cancer patients. More than 100 precision therapies involving both solid and liquid malignancy have since been approved by FDA as indicated therapy in a variety of cancer types as related to correlated molecular target. We provide clinical justification of consideration for precision therapy guided by matched molecular target, specifically focusing on PI3K/mTOR/AKT, BRCA, CDK4/6, EGFR and BRAF V600E for advanced disease cancer patients who previously failed optimal NCCN guideline directed standard of care.
