AstraZeneca, Daiichi Sankyo's Enhertu gets FDA priority review in lung cancer subtype
yodiyim/iStock via Getty Images


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 non-small cell lung cancer (NSCLC) whose tumors have a HER2 (ERBB2) mutation and who have received a prior systemic therapy.

The FDA accepted the companies' supplemental biologics license application (sBLA) for Enhertu (fam-trastuzumab deruxtecan-nxki) and is expected to make a decision during Q3.
Under priority review, the FDAâs goal is to take action within six months, compared to 10 months under standard review.
The companies said the sBLA is backed by data from a phase 2 trial called DESTINY-Lung01, which was published in The New England Journal of Medicine, and is supported by a phase 1 trial (DS8201-A-J101) published in Cancer Discovery.