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FDA Approves Roche’s PATHWAY HER2 Test for Identifying HER2-Ultralow Breast Cancer Patients Eligible for ENHERTU

NextEdge Admin

01 Feb 2025

2 min 26 sec

Roche announced that the U.S. FDA has approved a label expansion for the PATHWAY® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody. This approval allows the test to identify patients with HR-positive, HER2-ultralow metastatic breast cancer who may be eligible for treatment with ENHERTU®. ENHERTU, a HER2-directed antibody-drug conjugate (ADC), was developed by Daiichi Sankyo and is jointly commercialized with AstraZeneca.

Historically, HER2 status was classified as either positive or negative. In 2022, HER2-low emerged as a new category, and now, HER2-ultralow has been introduced for patients with even lower HER2 expression. This breakthrough enables a broader group of patients to be considered for HER2-targeted therapy.

“The rising incidence of metastatic breast cancer highlights the urgent need for new diagnostic solutions,” said Matt Sause, CEO of Roche Diagnostics. “With this approval, we are providing new hope for patients previously ineligible for HER2-directed treatment.”

HER2 is a receptor protein that promotes cancer cell growth. Pathologists assess HER2 levels in breast cancer tissue samples to determine treatment options. The PATHWAY HER2 (4B5) test was integral to the DESTINY-Breast06 trial, which demonstrated a median progression-free survival of 13.2 months with ENHERTU compared to 8.1 months with chemotherapy in patients with HER2-low and HER2-ultralow metastatic breast cancer.

This FDA approval expands the use of Roche’s PATHWAY HER2 (4B5) test, reinforcing its role in breast cancer diagnostics. The test delivers reliable and timely results, further strengthening Roche’s comprehensive breast cancer portfolio and empowering clinicians with critical insights to improve patient outcomes.