Loading
A drug label says 'for PD-L1 positive patients' but does not say that other tests give different answers. Labels should list the validated tests and how much they disagree.
Labels reference the companion diagnostic used in the pivotal trial but not the performance of other assays commonly used in practice, leaving clinicians to guess whether their laboratory's test is equivalent. Requiring a structured concordance section (validated assays, concordance data with other widely used assays, known discordant regions) would surface the uncertainty and drive sponsors to generate bridging data.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Companion diagnostic, Companion diagnostics, Biomarkers are not validated or standardised.
Shares Companion diagnostic, Companion diagnostics, Biomarkers are not validated or standardised.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Companion diagnostic, Biomarkers are not validated or standardised.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Companion diagnostic, Biomarkers are not validated or standardised.
Shares Examination of Low ERBB2 Protein Expression in Breast Cancer Tissue, Companion diagnostic, Companion diagnostics, Biomarkers are not validated or standardised.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Knowledge reaches practice too slowly.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Knowledge reaches practice too slowly.
Shares FDA Oncology Approvals (OCE) & Novel Drug Approvals, Knowledge reaches practice too slowly.