The FDA approved a label expansion for Roche’s PATHWAY anti-HER2/neu (4B5) test to identify patients with HR-positive, HER2-ultralow metastatic breast cancer eligible for ENHERTU

HER2-ultralow is a newly designated category for patients with even lower HER2 expression than HER2-low, expanding potential treatment options

The PATHWAY HER2 (4B5) test was used in the DESTINY-Breast06 trial, where ENHERTU showed a median progression-free survival of 13.2 months versus 8.1 months with chemotherapy

The approval provides new hope for metastatic breast cancer patients, enabling HER2-targeted treatment for those previously classified as HER2-negative