Pharmacogenomics for Tailored Therapies in Labeling of FDA Oncology Drugs

• Activity Number: 548 - Innovative Methods in Precision Medicine
• Type: Topic Contributed
• Date/Time: Thursday, August 11, 2022 : 10:30 AM to 12:20 PM
• Sponsor: Biometrics Section
• Author(s): Danni Yu*
• Companies: Nektar Therapeutics
• Keywords: Pharmacogenomics (PGx); Clinical Trial; Review Oncology PGx; Companion Diagnosis Device (CDx); Baseline Biomarker; Precision Medicine

Abstract

Pharmacogenomics (PGx) in precision medicine is critical for a tailored therapy to identify a group of patients with better efficacy and safety. The table of PGx biomarkers published at an FDA website presented the information for more than 60 biomarkers included in the labeling of oncology drugs. A review on the statistical methods applied for the analysis on these biomarkers will be provided. The statistical study designs supporting the companion diagnostic device (CDx) for the corresponding therapeutic products will be discussed.