
Roche has secured a label expansion from the US Food and Drug Administration (FDA) for the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody.
This new approval allows for the identification of patients with hormone receptor (HR)-positive, HER2-ultralow metastatic breast cancer who may qualify for treatment with Enhertu (trastuzumab deruxtecan).
Enhertu is a HER2-directed antibody drug conjugate (ADC) developed and commercialised by Daiichi Sankyo and AstraZeneca.
The FDA recently approved the drug to treat adult patients with unresectable or metastatic HR-positive, HER2-low or HER2-ultralow breast cancer.
The PATHWAY HER2 (4B5) test was approved by the FDA as a companion diagnostic for assessing HER2-low status in 2022.
It can now be used for identifying a new category, HER2-ultralow. This designation refers to patients with extremely low HER2 expression, even lower than the existing HER2-low category.
The PATHWAY HER2 (4B5) test was used in the DESTINY-Breast06 trial, in which Enhertu showed superiority against chemotherapy with a median progression-free survival of over one year. An exploratory analysis confirmed consistent results across both groups.
The FDA’s approval of the HER2-ultralow indication expands the intended use of Roche’s PATHWAY anti-HER2 (4B5) test. This advancement enhances Roche’s breast cancer portfolio, supporting informed decision-making to improve patient outcomes.
In 2022, Roche secured FDA approval for the PATHWAY test to identify metastatic breast cancer patients with low HER2 expression for treatment with Enhertu.
Roche Diagnostics CEO Matt Sause said: “One in eight women in the US 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.”
Roche’s pre-diluted PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody, used with the fully automated BenchMark IHC/ISH slide staining instrument, standardises immunohistochemistry (IHC) processes from baking through staining.
This reduces human error and minimises variability found in manual and semi-automated methods, Roche said.
In November last year, the Swiss healthcare firm secured FDA approval for the PATHWAY test to identify patients with biliary tract cancer eligible for HER2-targeted treatment with Jazz Pharmaceuticals’ Ziihera (zanidatamab-hrii).