FDA Expands Labeling for Roche’s Pathway Rabbit Monoclonal Primary Antibody in Patients with Biliary Tract Cancer

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The FDA has approved a label expansion for Roche’s Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody test. According to the company, this is the first FDA-approved companion diagnostic for identifying HER2-positive biliary tract cancer (BTC) patients eligible for treatment with Jazz Pharmaceuticals' Ziihera (zanidatamab-hrii). Additionally, Ziihera is he first FDA-approved treatment for adults with previously treated, unresectable or metastatic HER2-positive (IHC 3+) BTC.¹

"This test is a step forward in furthering access to personalized medicine," said Jill German, head, pathology lab, Roche Diagnostics, in a press release. "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."

According to Roche, the Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody delivers timely, clear and reliable results, enabling therapeutic decisions that can lead to better outcomes for patients. Currently, the antibody is indicated as an aid to identify breast cancer patients eligible for HER2-targeted treatment with Herceptin, Kadcyla, and Enhertu. Further, it is used in combination with the fully automated Ventana BenchMark slide staining instrument. Roche states that it standardizes all immunohistochemistry (IHC) processes from baking through staining and reduces the possibility of human error and minimizes inherent variability resulting from individual reagent dilution and other processes found in manual and semi-automated IHC methods.¹

BTC comprises 3% of gastrointestinal cancers in the United States, with most cases diagnosed at advanced stages and a five-year survival rate as low as 3% for metastatic disease and 19% for disease that is localized to the original tumor site.1 According to the American Cancer Society, 8,000 people in the United States are diagnosed with bile duct cancer on an annual basis, including both inside and outside the liver. Despite these confirmed numbers, it is possible that numbers could be higher due to the cancers being difficult to detect. While it is mainly found in older people, younger people can experience it as well. The average age of people in the US diagnosed with bile duct cancer is in the 70s.²

According to the National Cancer Institute, there have been around 41,630 cases of bile duct cancer confirmed this year, representing 2.1% of all cancer cases. This has resulted in 29,840 deaths, representing 4.9% of all cancer related deaths this year. Additionally, the rate of new cases was 9.4 per 100,000 men and women per year. In the United States, approximately 1.1% of men and women will be diagnosed with liver and intrahepatic bile duct cancer at some point during their lifetime, based on 2018–2021 data, excluding 2020 due to COVID-19.³

Nearly all bile duct cancers are cholangiocarcinomas, which are a type of adenocarcinomas. Other less common forms include sarcomas, lymphomas, and small cell cancers. Additionally, hepatocellular carcinoma is the most common type of cancer that starts in the liver.⁴

References

1. Roche receives FDA approval for first companion diagnostic to identify patients with biliary tract cancer eligible for HER2-targeted treatment with ZIIHERA. PR Newswire. November 25, 2024. Accessed November 25, 2024. https://www.prnewswire.com/news-releases/roche-receives-fda-approval-for-first-companion-diagnostic-to-identify-patients-with-biliary-tract-cancer-eligible-for-her2-targeted-treatment-with-ziihera-302314548.html

2. Key Statistics for Bile Duct Cancer. American Cancer Society. Accessed November 25, 2024. https://www.cancer.org/cancer/types/bile-duct-cancer/about/key-statistics.html

3. Cancer Stat Facts: Liver and Intrahepatic Bile Duct Cancer. NIH. Accessed November 25, 2024. https://seer.cancer.gov/statfacts/html/livibd.html

4. What Is Bile Duct Cancer? American Cancer Society. Accessed November 25, 2024. https://www.cancer.org/cancer/types/bile-duct-cancer/about/what-is-bile-duct-cancer.html