FDA Approves Roche's First HER2 Companion Diagnostic for Biliary Tract Cancer

Roche has announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for their PATHWAY® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test. This test is now the first FDA-approved companion diagnostic to identify patients with HER2-positive biliary tract cancer (BTC) who may be suitable for treatment with ZIIHERA® (zanidatamab-hrii) from Jazz Pharmaceuticals.

The PATHWAY HER2 (4B5) test is designed to detect the presence of the HER2 protein, which is a biomarker that can indicate whether a patient will respond to HER2-targeted therapies. Prior to this approval, there was no validated HER2 test for BTC patients. Jill German, Head of Pathology Lab at Roche Diagnostics, emphasized that this test could significantly improve the prognosis for BTC patients, who typically have limited treatment options.

BTC accounts for a small percentage of all gastrointestinal cancers in the United States, with poor outcomes due to advanced diagnosis stages and aggressive tumor biology. The five-year survival rate for localized BTC is 19%, plummeting to just 3% when the cancer has metastasized.

The newly approved indication expands the clinical utility of the PATHWAY HER2 (4B5) test, previously used to identify breast cancer patients eligible for treatments like Herceptin®, KADCYLA®, or ENHERTU®. This test integrates seamlessly with Roche's VENTANA® BenchMark slide staining instrument, standardizing IHC processes and reducing potential errors associated with manual methods.

Roche, founded in 1896 in Basel, Switzerland, has become a leader in biotechnology and in-vitro diagnostics. The company's focus on scientific excellence has driven significant advancements in personalized healthcare, aiming to transform healthcare delivery and improve patient outcomes.

Roche's commitment to innovation and sustainability has been a cornerstone of its operations for over 125 years. The company strives to develop medicines and diagnostics that contribute to healthier lives and has set ambitious goals for achieving net zero emissions by 2045 through initiatives like the Science Based Targets initiative and the Sustainable Markets Initiative.

In the United States, Roche's subsidiary Genentech is a key player, and Roche holds a majority stake in Japan's Chugai Pharmaceutical. This global footprint allows Roche to leverage extensive expertise and resources to advance healthcare worldwide.

In conclusion, the FDA's approval of the expanded use of the PATHWAY HER2 (4B5) test for BTC patients represents a significant advancement in the field of personalized medicine. This test not only offers BTC patients new hope for targeted treatment but also underscores Roche's ongoing commitment to delivering innovative healthcare solutions.