Roche’s PATHWAY HER2 Test Gains FDA Approval For HER2-Ultralow Breast Cancer

Roche has announced that the FDA has approved an expanded use of its PATHWAY® anti-HER2 (4B5) test. This test can now help identify patients with HR-positive, HER2-ultralow metastatic breast cancer who may benefit from treatment with ENHERTU®, a targeted ADC therapy developed by Daiichi Sankyo and AstraZeneca. Previously, breast cancer was classified as either HER2-positive or HER2-negative based on HER2 protein levels. In 2022, a new category, HER2-low, was introduced, and now the FDA has approved an even more refined category, HER2-ultralow. 

Matt Sause, CEO of Roche Diagnostics, said in a statement, “One in eight women in the United States will face invasive breast cancer in their lifetime. The rising incidence of metastatic breast cancer, particularly among younger populations, underscores the urgent need for new diagnostic options. The approval of our test for determining HER2-ultralow status offers new hope to patients by providing a possible path to HER2-targeted treatment where none existed before, helping clinicians transform outcomes for many facing this challenging disease.” 

The group includes patients with very minimal HER2 expression, offering them new potential treatment options. The PATHWAY HER2 (4B5) test played a key role in the DESTINY-Breast06 trial, where ENHERTU showed promising results. Patients with HER2-low and HER2-ultralow breast cancer who received ENHERTU had a median progression-free survival of 13.2 months, compared to 8.1 months for those on standard chemotherapy. These findings were consistent across both HER2-low and HER2-ultralow groups.