AstraZeneca, Daiichi Sankyo's Enhertu gets FDA breakthrough therapy tag for breast cancer subtype
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The Food and Drug Administration (FDA) granted breakthrough therapy designation to AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo's (OTCPK:DSKYF) (OTCPK:DSNKY) Enhertu to treat certain patients with breast cancer.
The FDA status for Enhertu is to treat adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-negative) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

Patients with hormone receptor (HR) positive breast cancer should additionally have received or be ineligible for endocrine therapy, the companies said in an April 26 release.
The companies noted that the FDA's decision was backed by data from a phase 3 trial, called DESTINY-Breast04, in which Enhertu showed a statistically significant and clinically meaningful improvement in progression-free survival and overall survival, compared to chemotherapy, which is the current standard of care.
Earlier in April, Enhertu received FDA's priority review to treat certain patients with non-small cell lung cancer.