AstraZeneca, Daiichi Sankyo's Enhertu gets approval in EU for breast cancer subtype
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The European Commission (EC) approved AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo's (OTCPK:DSKYF) (OTCPK:DSNKY) drug Enhertu to treat certain patients with a type of breast cancer.
Enhertu (trastuzumab deruxtecan) can now be used in the EU as a monotherapy to treat adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

The EC approval follows the positive opinion from a committee the European Medicines Agency based on data from a phase 3 trial called DESTINY-Breast04.
"The approval of Enhertu in HER2-low metastatic breast cancer represents a significant clinical advance for patients in Europe with both HR-positive and HR-negative disease who previously have had limited treatment options in the late-line setting," said Ken Keller, global head of Oncology Business, and President and CEO, Daiichi Sankyo.
Following this EU approval, Daiichi Sankyo will get $150m from AstraZeneca as a milestone payment under their collaboration agreement.