NEW YORK – Roche announced Monday that its Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test has received approval from the US Food and Drug Administration for use as a companion diagnostic with Jazz Pharmaceuticals' Ziihera (zanidatamab-hrii) in biliary tract cancer (BTC) patients.
The test is used to identify patients with previously treated, unresectable, or metastatic HER2-positive biliary tract cancer who may be eligible for treatment with Ziihera. The assay is used with Roche's Ventana BenchMark slide staining instrument and standardizes all immunohistochemistry processes from baking through staining, Roche said in a statement.
The test was previously approved as a companion diagnostic for breast cancer patients who may be eligible for HER2-targeted treatment with Genentech's Herceptin (trastuzumab), Genentech's Kadcyla (ado-trastuzumab emtansine), or Daiichi Sankyo's Enhertu (trastuzumab deruxtecan).
"This test is a step forward in furthering access to personalized medicine," Jill German, Roche Diagnostics' head of pathology lab, said in a statement. "The prognosis for patients diagnosed with BTC is poor, as very few treatment options exist. Now, these patients have access to the first standardized test that could make them eligible for targeted therapy, potentially improving clinical outcomes."
Ziihera, a HER2-targeted bispecific antibody, received accelerated approval from the FDA last week.