AstraZeneca (AZN) and Daiichi Sankyo said Monday the US Food and Drug Administration granted priority review to their supplemental application for the breast cancer medication Enhertu.
A late-stage clinical trial demonstrated Enhertu lowered the risk of disease recurrence or mortality by 53%, and brain metastasis-free interval by 36% compared to the traditional treatment, trastuzumab emtansine, the companies said.
The targeted therapy is intended for adult patients with Her2 early breast cancer who exhibit residual invasive disease following prior treatments, they said.
The clinical data also revealed higher rates of lung inflammation for the new medication, with interstitial lung disease occurring in 9.6% of patients taking Enhertu compared to 1.6% for the standard regimen, the companies said.
The federal health agency established a target action date of July 7 to finalize its regulatory decision on the application, they added.
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