Hosted on MSN24y
What Immunohistochemistry (IHC) Can Tell You
Medically reviewed by Doru Paul, MD Immunohistochemistry (IHC) is a special test used by pathologists to detect specific ...
Targeted Oncology2d
FDA Expands PATHWAY HER2 (4B5) Test to Include HER2-Ultralow Status
The PATHWAY HER2 (4B5) test is now FDA-approved to assess HER2-ultralow status in metastatic breast cancer, expanding its ...
The American Journal of Managed Care7d
FDA Approves First HER2-Ultralow Companion Diagnostic, Expanding Treatment Eligibility
Roche’s PATHWAY HER2 (4B5) test helps identify patients with HER2-ultralow breast cancer, who may be eligible for targeted ...
Pharm Exec10d
FDA Approves AstraZeneca, Daiichi Sankyo’s Enhertu for Unresectable or Metastatic Hormone Receptor-Positive, HER2-Low Breast Cancer
Approval of Enhertu marks the first HER2-directed therapy indicated for adults with unresectable or metastatic HR-positive, ...
Targeted Oncology10d
FDA Approves T-DXd in HR+, HER2-Low/Ultralow Breast Cancer
The FDA approved trastuzumab deruxtecan for adult patients with unresectable or metastatic HER2-low or HER2-ultralow breast ...
The American Journal of Managed Care10d
FDA Approves Trastuzumab Deruxtecan for HER2-Low/Ultralow Breast Cancer
The approval is based on findings from a phase 3 study which demonstrated the drug’s superiority over chemotherapy.
Contract Pharma10d
AstraZeneca & Daiichi Sankyo’s Enhertu Approved by FDA for Treatment of Metastatic Breast Cancer
New approval brings the medicine to an earlier treatment setting and a broader patient population.
Hosted on MSN2mon
Roche secures CE mark for ovarian cancer detection test
Roche has secured CE mark approval for its immunohistochemistry (IHC) companion diagnostic test, VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, for the identification of epithelial ovarian cancer (EOC ...
pharmaphorum10d
Enhertu gets first okay for HER2-ultralow breast cancer
AstraZeneca and Daiichi Sankyo have claimed their seventh FDA approval for Enhertu, getting the go-ahead for the blockbuster ...
FDA approval expands earlier use of Enhertu for metastatic breast cancer
The U.S. Food and Drug Administration has approved Enhertu (trastuzumab deruxtecan) for the treatment of adult patients with ...
pharmaphorum10mon
Roche gets EU okay for first HER2-low test kit
The availability of a simple immunohistochemical (IHC) test for HER2-low status is seen as critical to the successful rollout of Enhertu (trastuzumab deruxtecan) in this category of breast cancer ...