FDA Approves Roche Companion Diagnostic to Identify Eligibility for Enhertu

The FDA has approved Roche Diagnostic’s Pathway anti-HER2 (4B5) test to identify metastatic breast cancer patients with low HER2 expression who may benefit from AstraZeneca and Daiichi Sankyo’s Enhertu (fam-trastuzumab deruxtecan-nxki).

The test includes a scoring algorithm that helps pathologists to identify low expressors of HER2.

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, the company said.

The approval expands the use of Roche’s test, which is also indicated as an aid in assessing breast cancer patients for treatment with Genentech’s Herceptin (trastuzumab) or Kadcyla (ado-trastuzumab emtansine).