Devices

Roche’s Pathway Test OK’d for Low HER2

FDA has approved a Roche PMA for the Pathway anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody to identify metastatic breast cancer patients with low HER2 expression for whom AstraZeneca and Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki) may be considered as a targeted treatment.

Roche says HER2 is a receptor protein that helps cancer cells grow. “If a patient's tumor expresses high levels of HER2, the patient is identified as HER2-positive and may be considered for HER2-targeted treatment,” it says. “However, half of all patients with metastatic breast cancer express low levels of HER2 which historically classified them as HER2-negative.”

The Pathway test includes a scoring algorithm that helps identify HER2 low expressors who may benefit from Enhertu as a treatment option. “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,” Roche says. “Now, they may be eligible for a HER2-targeted therapy, significantly increasing the number of patients who could have improved outcomes.”

The company notes that the test was used as part of the DESTINY-Breast04 trial to identify patients whose tumors expressed low levels of HER2 protein. “The trial reported a 50% reduction in the risk of disease recurrence or death and an overall gain of six months over standard of care in patients treated with ENHERTU whose tumors had low levels of HER2 expression,” it says.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome