FDA Expands Labels For Roche's HER2 CDx Assays to ID Breast Cancer Patients Eligible For Enhertu

Original from: genomeweb

Roche said Monday that the US Food and Drug Administration has approved the company's Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody and Ventana HER2 Dual ISH DNA Probe Cocktail tests, clearing them for identifying HER2-positive metastatic breast cancer (mBC) patients who may be eligible for treatment with AstraZeneca's Enhertu (trastuzumab deruxtecan). 

The Pathway assay had previously been approved for identifying mBC patients with HER2-low and HER2-ultralow expression. The expanded approval enables Pathway and Ventana to be used together to identify Enhertu-eligible patients across the full spectrum of HER2 expression. 

Also on Monday, AstraZeneca announced that the FDA approved Enhertu in combination with Genentech's Perjeta (pertuzumab) as a first-line treatment for adults with unresectable or metastatic HER2-positive breast cancer. 

"Metastatic breast cancer remains a significant challenge," Laura Apitz, head of the pathology lab at Roche Diagnostics, said in a statement. "With this approval, our breast diagnostic portfolio can further guide therapy decisions for clinicians, enabling a more personalized approach."

Roche also recently gained CE-IVDR marking for the Ventana assay in Europe.

Source:  FDA Expands Labels For Roche's HER2 CDx Assays to ID Breast Cancer Patients Eligible For Enhertu