AstraZeneca, Daiichi win two FDA breakthrough tags for Enhertu
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AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo (OTCPK:DSKYF) (OTCPK:DSNKY) have received two breakthrough therapy designations from the U.S. FDA for Enhertu (fam-trastuzumab deruxtecan-nxki) as a treatment for HER2-positive solid tumors and colorectal cancers.
The companies said that HER2 overexpression has been seen in between 1% and 28% of solid tumors and up to 5% of colorectal cancer cases.


The status was granted based on phase 2 studies in each indication.
Enhertu is an antibody-drug conjugate developed and commercialized jointly by AstraZeneca (AZN) and Daiichi Sankyo (OTCPK:DSKYF).


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