FDA Approves FoundationOne CDx for EGFR Inhibitors to Identify EGFR Mutations in NSCLC
The FoundationOne CDx test will be used to identify patients for treatment with FDA-approved EGFR inhibitors.
FDA Approves Thermo Fisher Scientific Oncomine Dx Assay as CDx for Janssen Lung Cancer Drug
The Oncomine Dx Target Test will be used as a companion diagnostic to identify NSCLC patients whose tumors carry EGFR Exon20-insertion mutations.
FDA Approves Takeda's Exkivity With Thermo Fisher CDx for EGFR Exon20 Insertion-Positive NSCLC
This is the first time the FDA has approved a drug specifically for NSCLC patients who harbor rare EGFR Exon20 insertion mutations.
Genecast to Evaluate Liquid Biopsy EGFR Mutation Test in Early-Stage Non-Small Cell Lung Cancer
The firm hopes its qPCR-based liquid biopsy test could help identify early-stage NSCLC patients eligible for adjuvant or neoadjuvant anti-EGFR TKI treatment.
FDA Approves Janssen's Rybrevant, Guardant360 CDx for EGFR Exon 20-Mutated NSCLC
The agency approved amivantamab for non-small cell lung cancer patients harboring EGFR exon 20 mutations, as detected by Guardant Health's blood-based test.