Roche: breast cancer test approved by FDA

(CercleFinance.com) - Roche has announced that the US FDA has approved its PATHWAY anti-HER2 (4B5) test to identify patients with metastatic breast cancer with low HER2 expression for whom Enhertu can be considered as a targeted therapy.


The test now includes a scoring algorithm to help identify "low expressors" of HER2. With this lower threshold, the test is able to identify patients who may benefit from Enhertu as a treatment option.

Breast cancer has overtaken lung cancer as the most frequently diagnosed cancer, with approximately 2.3 million new cases worldwide each year. Over 620,000 people die from breast cancer each year, Roche said.


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