IHC
Elevation Oncology Narrows EO-3021 Trial to Claudin 18.2-Expressing Patients, Launches Combo Cohorts
The firm is using immunohistochemistry to gauge biomarker expression before enrolling patients in a trial of its CLDN 18.2-directed antibody-drug conjugate.
I-Mab Streamlines Operations, Focuses Pipeline on CLDN18.2-Directed Therapy
The firm is shifting its resources to fund and expand its Phase I clinical trial of givastomig in CLDN18.2-expressing advanced solid tumor patients.
HER2 Biomarker Evolving as Enhertu Shows Activity in Breast Cancers With Ultralow Expression
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The new HER2-low category is exposing the limitations of IHC testing, challenging pathologists, and has oncologists revisiting patients' old test results.
FDA Approves Roche CDx Test for Use With Jazz Pharmaceuticals Drug in Biliary Tract Cancer
The approval is for a new indication for Roche's existing Pathway HER2 (4B5) test and is intended to identify patients with HER2-positive biliary tract cancer.
Jazz Pharmaceuticals Nabs FDA Accelerated Approval for Ziihera in HER2-Positive Biliary Tract Cancer
The approval is based on the objective response rate in a Phase IIb trial of previously treated, unresectable or metastatic biliary tract cancer patients.