Original from: Roche
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved a label expansion for the PATHWAY® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody* to identify patients with HR-positive, HER2-ultralow metastatic breast cancer who may be eligible for treatment with ENHERTU®. ENHERTU is a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by Daiichi Sankyo and AstraZeneca.
Until the introduction of HER2-low status in 2022, HER2 status was categorised as either ¡°positive¡± or ¡°negative¡± based on the level of HER2 expression. The PATHWAY HER2 (4B5) test has now received approval to identify a new patient population designated as "HER2-ultralow." HER2-ultralow refers to patients who have very low levels of HER2 expression, even lower than the existing HER2-low category.
¡°One in eight women in the United States will face invasive breast cancer in their lifetime,¡± said Matt Sause, CEO of Roche Diagnostics. ¡°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.¡±
HER2 is a receptor protein that helps cancer cells grow quickly. To determine a patient¡¯s HER2 status, pathologists evaluate, or score, the level of HER2 receptor protein expressed in breast cancer tissue samples. The PATHWAY HER2 (4B5) test was used as part of the DESTINY-Breast06 trial, which showed a median progression-free survival of 13.2 months with ENHERTU compared to 8.1 months with the standard of care (chemotherapy) in the overall trial population of patients with HER2-low and HER2-ultralow metastatic breast cancer. An exploratory analysis showed the results were consistent between patients with HER2-low and HER2-ultralow expression.
The FDA approval of the new HER2-ultralow indication expands on the intended use for Roche¡¯s on-market PATHWAY anti-HER2 (4B5) test, proven in delivering timely, clear, and confident results. The launch further strengthens and differentiates Roche¡¯s comprehensive breast cancer solutions portfolio, aiding patients and providers in making informed decisions to improve outcomes.
