AstraZeneca, Daiichi Sankyo's Enhertu gets FDA priority review for breast cancer subtype
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The U.S. Food and Drug Administration (FDA) granted priority review to AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo's (OTCPK:DSKYF) (OTCPK:DSNKY) Enhertu to treat adult patients with unresectable or metastatic HER2-low (immunohistochemistry (IHC) 1+ or IHC 2+/in-situ hybridization (ISH)-negative) breast cancer who have received a prior therapy in the metastatic setting.

The FDA accepted the companies' supplemental biologics license application (sBLA) for Enhertu (trastuzumab deruxtecan) and is expected to make a decision during Q4.
Under priority review, the FDA's goal is to take action within six months, compared to 10 months under standard review.
In April, the FDA had granted breakthrough therapy designation to Enhertu for the same use.
The companies said the sBLA is backed by data from a phase 3 trial called DESTINY-Breast04.
"If approved, Enhertu will redefine how we classify and treat metastatic breast cancer, enabling patients whose tumours have lower levels of HER2 expression the opportunity to benefit from a HER2-directed therapy," said Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca.
Enhertu is also under priority review by the FDA to treat certain patients with non-small cell lung cancer.