Roche receives FDA approval for first companion diagnostic

• Approximately half of all patients with metastatic breast cancer (mBC) express low levels of HER2. These patients with HER2 low status may now be eligible for a targeted treatment, which could significantly improve their outcomes.^1,2
• The PATHWAY anti-HER2 (4B5) test is the only FDA approved companion diagnostic indicated as an aid in the assessment of HER2 low status in metastatic breast cancer patients. These patients may now consider ENHERTU as a treatment option based on the results of the Phase 3 DESTINY-Breast04 trial.³

Basel, 4 October 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) approved the PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody* to identify metastatic breast cancer patients with low HER2 expression for whom ENHERTU^® (fam-trastuzumab deruxtecan-nxki) may be considered as a targeted treatment. ENHERTU is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

HER2 is a receptor protein that helps cancer cells grow quickly. To determine a patient’s HER2 status, pathologists evaluate, or score, the level of HER2 receptor protein expressed in breast cancer tissue samples. If a patient’s tumour expresses high levels of HER2, the patient is identified as HER2-positive and may be considered for HER2-targeted treatment. However, half of all patients with metastatic breast cancer express low levels of HER2 which historically classified them as HER2-negative.

The PATHWAY anti-HER2 (4B5) test now includes a scoring algorithm that helps pathologists to identify “low expressors” of HER2, assigning a HER2 low status to this group of patients. With this lower cutoff, the test is able to identify patients who may benefit from ENHERTU as a treatment option.

“Roche is proud to lead the way in HER2 diagnostics through critical innovations that support the identification of patients who…