FDA Approves Companion Diagnostic for Patients with Breast Cancer, Low HER2 Expression
The FDA approved a companion diagnostic to aid in the identification of patients with HER2-low metastatic breast cancer who may be candidates for treatment with fam-trastuzumab deruxtecan-nxki, according to a press release issued by Roche.
The PATHWAY anti-HER2 (4B5) Rabbit Monoclonal Primary Antibody Test uses a scoring algorithm designed to recognize patients with low expression of HER2, a receptor protein associated with cancer growth.
To date, it is the only FDA-approved companion diagnostic designed specifically to identify low HER2 expression.
Approval was based on data from the DESTINY-Breast04 study, which identified and treated patients based on low levels of HER2 expression.
The study reported a 50% reduction in the risk of death or disease recurrence, as well as a 6-month survival gain compared to standard of care for patients treated with fam-trastuzumab deruxtecan-nxki.
“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,” according to Thomas Schinecker, PhD, CEO of Roche Diagnostics, in the release
--
Reference:
https://www.roche.com/media/releases/med-cor-2022-10-04
Disclosures: Schinecker is an employee of Roche. DESTINY-Breast04 is being supported by Daiichi Sankyo and AstraZeneca.
Photo Credit: Getty Images.
By Cameron Kelsall, MD /alert Contributor