IHC
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.
Roche CDx Test Receives CE Marking for Use in Gastric Cancer Patients
The IHC companion diagnostic test determines CLDN18 protein expression and may help identify patients who are eligible for treatment with Vyloy.
TORL BioTherapeutics' CLDN6-Targeting Antibody-Drug Conjugate Demonstrates Encouraging Early Results
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Phase I data presented at ESMO suggested that TORL-1-23 may have particularly strong activity in CLDN-positive advanced ovarian cancer.