Codevelopment of genome-based therapeutics and companion diagnostics: Insights from an institute of medicine roundtable
Cet article présente le résumé d'une table-ronde organisée par l'Institute of Medicine aux Etats-Unis sur le co-développement de thérapies ciblées et de tests compagnons
More than 100 therapeutics, mostly for oncology, have biomarker tests recommended in their US Food and Drug Administration (FDA) labels. Moreover, a strategy to codevelop and cosubmit to the FDA a diagnostic test (companion diagnostic [CoDx]) that specifically targets a drug to patients predicted to respond has had success recently with vemurafenib, targeting the BRAF V600 mutation in metastatic melanoma, and with crizotinib, targeting the EML4-ALK mutation in non–small cell lung cancer. Companion diagnostic tests define the subset of patients who are most likely to benefit from a therapy or who should not receive the therapy because of ineffectiveness or predicted adverse effects. Genome-based, targeted therapeutics and codeveloped CoDx tests are the foundation of personalized medicine and have potential for contributing to high-value health care.
JAMA , article en libre accès, 2013