HER2 Biomarkers
NICE Recommends Lynparza for BRCA1/2-Mutant Breast Cancer
The institute originally began reviewing Lynparza in this setting in 2018 but ended its review due to lack of evidence.
Biomarker-Targeted Therapy in 2025: Precise Patient Selection, MRD, Antibody-Drug Conjugates
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The already crowded field of biomarker-targeted drugs is poised to only get busier with new biomarkers, ADCs, and cancer vaccines.
FDA Issues Draft Guidance on Tissue Biopsies in Clinical Trials
The agency affirmed the use of biopsies for biomarker-driven trials but cautioned against optional biopsies that offer little value to the patient or trial.
Guardant Health, Boehringer Ingelheim Partner on Companion Diagnostic for New Lung Cancer Drug
The companies aim to establish Guardant360 CDx as a tool to identify patients with HER2 mutations eligible for treatment with the targeted drug zongertinib.
The model uses clinical and genomic features to predict whether patients will respond to first-line CDK4/6 and endocrine therapy.