Roche receives FDA approval for first companion diagnostic to identify patients with biliary tract cancer eligible for HER2-targeted treatment with ZIIHERA

Original from: PR Newswire

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the U.S. Food and Drug Administration (FDA) approval of a label expansion into biliary tract cancer (BTC) for the PATHWAY® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody* test. This test is now the first and only FDA-approved companion diagnostic to aid in the assessment of HER2-positive status to identify BTC patients who are eligible for treatment with Jazz Pharmaceuticals' ZIIHERA® (zanidatamab-hrii).

HER2 is a receptor protein expressed in a variety of cancers and serves as a predictive biomarker to help determine if a patient will respond to HER2-targeted therapy. No approved and validated HER2 test existed to identify eligible BTC patients until the approval of this expanded label for the PATHWAY HER2 (4B5) test. 

"This test is a step forward in furthering access to personalised medicine," said Jill German, Head of Pathology Lab at Roche Diagnostics. "The prognosis for patients diagnosed with BTC is poor, as very few treatment options exist. Now, these patients have access to the first standardised test that could make them eligible for targeted therapy, potentially improving clinical outcomes."

ZIIHERA is the first FDA-approved treatment for adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) biliary tract cancer.

BTC accounts for 3% of all gastrointestinal cancers in the US. Prognosis is poor because of a lack of adequate early detection tools, challenging anatomical access, aggressive tumour biology, and only modest benefit from systemic treatments. With most cases diagnosed at an advanced stage, the five-year overall survival rate for all BTC cases is 19% for disease that is localised to the original tumour site, and just 3% for cancer that has spread to other areas.

Source: Roche receives FDA approval for first companion diagnostic to identify patients with biliary tract cancer eligible for HER2-targeted treatment with ZIIHERA