Abstract 2103: Pharmacogenomic biomarkers of oncology drugs approved by the US FDA classified on the basis of BEST (Biomarkers, EndpointS, and other Tools) resource: systematic review

Abstract Objective: To characterize pharmacogenomic biomarkers of oncology indications approved by the US FDA classified on the basis of BEST (Biomarkers, EndpointS, and other Tools). Resource Design: Systematic review. Data sources: FDA oncology/hematologic malignancies approvals and databases, BEST (Biomarkers, EndpointS, and other Tools) Resource, and CDER / CBER’s DDT Qualification Project Search database: Stage 1: Letter of Intent (LOI), Stage 2: Qualification Plan (QP), and Stage 3: Full Qualification Package (FQP). Study Inclusion: All Biomarkers include germline or somatic gene variants (polymorphisms, mutations), functional deficiencies with a genetic etiology, gene expression differences, chromosomal abnormalities; and selected protein biomarkers in all approved labeling sections published by the FDA. Results: BEST Resource defines seven biomarker categories: susceptibility/risk, diagnostic, monitoring, prognostic, predictive, pharmacodynamic/response, and safety. The biomarkers are more linked to three cancers: breast, lung and colorectal cancers. Citation Format: Tariq H. Alqurayshah, SFDA Oncology and Hematology Group. Pharmacogenomic biomarkers of oncology drugs approved by the US FDA classified on the basis of BEST (Biomarkers, EndpointS, and other Tools) resource: systematic review [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2025; Part 1 (Regular Abstracts); 2025 Apr 25-30; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2025;85(8_Suppl_1):Abstract nr 2103.