AstraZeneca, Daiichi Sankyo's Enhertu wins FDA approval to treat breast cancer subtype
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The U.S. Food and Drug Administration (FDA) approved AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo's (OTCPK:DSKYF) (OTCPK:DSNKY) Enhertu to treat certain patients with breast cancer.
Enhertu (fam-trastuzumab deruxtecan-nxki) can now be used to treat adult patients with unresectable or metastatic HER2 positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.
Due to this U.S. approval, AstraZeneca will pay $100M to Daiichi Sankyo as a second-line milestone payment in HER2 positive metastatic breast cancer.
The companies said the previously granted accelerated approval of Enhertu in later line HER2 positive metastatic breast cancer is now converted to regular approval, which broadens its breast cancer indication in the U.S. to earlier lines of use in patients with HER2 positive metastatic breast cancer.
The approval was granted under the FDA's Real-Time Oncology Review (RTOR) program following recent priority review and breakthrough therapy designation of Enhertu in the U.S in this earlier disease setting, the companies said in a May 5 press release.
The approval was backed by data from a phase 3 trial, dubbed DESTINY-Breast03, which showed Enhertu reduced the risk of disease progression or death by 72% versus trastuzumab emtansine.
The companies added that Enhertu carries a Boxed Warning or interstitial lung disease/pneumonitis and Embryo-Fetal toxicity.
The companies noted that as part of Project Orbis, Enhertu is also is under regulatory review for the same use in Australia, Brazil, Canada, Israel and Switzerland.