Regulatory Roche Gets FDA Nod For Companion Diagnostic to Support...

Roche Gets FDA Nod For Companion Diagnostic to Support Breast Cancer Therapy


Roche Diagnostics has announced that it has received FDA approval for the very first companion diagnostic that aids in the identification of patients with HER2-low metastatic breast cancer. 

Health professionals have found Enhertu to be the targeted treatment for the majority of these patients, which is a specially formulated HER2-directed antibody drug that Daiichi Sankyo and AstraZeneca are working together on to develop and market.

Breast tumors that were previously much more difficult to identify, relying heavily on negative and positive labels, can now be precisely classified as HER2-low. 

HER2 a type of receptor protein which leads to rapid growth in cancer cells. 

Pathologists assess the presence of HER2 receptor proteins in breast cancer tissue specimens from patients to determine their HER2 status. A person is said to be HER-positive if their tumor exhibits high levels of HER2, making them eligible for therapies aimed at the condition. But historically, low HER2 levels have been identified in 50% of all patients with metastatic breast cancer, designating them as HER2-negative.

The PATHWAY anti-HER2 test contains an evaluation system that helps experts pinpoint “low expressors” of HER2 – these individuals are given HER2 low status. Since this examination has a lower cutoff, it can identify with greater accuracy the patients who could make the most of the Enhertu treatment option.

Thomas Schinecker, Chief Executive Officer of Roche Diagnostics, stated, “Roche is proud to lead the way in HER2 diagnostics through critical innovations that support the identification of patients who may benefit from novel HER2-targeted therapies. Previously, metastatic breast cancer patients with a lower level of HER2 expression were considered to be part of the HER2-negative population and had no HER2-targeted treatment options. Now, they may be eligible for a HER2-targeted therapy, significantly increasing the number of patients who could have improved outcomes.”

AstraZeneca and Daiichi Sankyo’s DESTINY-Breast04 trial used the PATHWAY anti-HER2 test to find patients with little to no HER2 protein levels in their tumors. The trial’s findings showed that patients with low HER2 expression levels who received Enhertu treatment experienced a 50% reduction in their risk of dying from their illness or having it come back.

With north of 2 million new cases diagnosed around the world every year, breast cancer has left behind lung cancer to take the top spot for the most commonly diagnosed cancer. Over 600,000 people perish from this form of cancer each year.

According to the National Cancer Institute, between 80 and 85 percent of the more than 280,000 new cases of breast cancer expected to be diagnosed in the U.S. this year would have been regarded as HER2-negative by prior definitions. Of those, 60% could be termed as HER2-low. However, Roche estimates that nearly 50% of all patients with metastatic breast cancer fall into the HER2-low category. Experts are confident that Enhertu will be more effective than the company’s prior HER2-targeting therapies, Kadcyla and Herceptin, which had little effect on HER2-low patients.

The FDA’s approval of the companion diagnostic is a significant victory for Roche, demonstrating its dedication to innovating and bringing high-value solutions on a constant basis to advance healthcare.

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