AstraZeneca and Daiichi Sankyo have announced that the FDA has granted Priority Review to the supplemental biologics license application (sBLA) for Enhertu (fam-trastuzumab deruxtecan-nxki) as a post-neoadjuvant treatment for patients with HER2-positive early breast cancer who are at high risk of disease recurrence. The application is based on results from the Phase III DESTINY-Breast05 trial in this setting.
In DESTINY-Breast05, Enhertu significantly reduced the risk of invasive disease recurrence or death by 53% versus ado-trastuzumab emtansine (T-DM1), the current standard of care in this post-neoadjuvant population, according to the companies. The trial evaluated Enhertu in patients with residual invasive disease after neoadjuvant therapy, a group considered at higher risk for recurrence.
The FDA’s Priority Review designation is intended to expedite the review of applications for medicines that may offer significant improvements in safety or efficacy over existing therapies. AstraZeneca and Daiichi Sankyo stated that the FDA has set a Prescription Drug User Fee Act (PDUFA) date for its decision, although specific timing details were not disclosed in the announcement.
Enhertu is a HER2-directed antibody drug conjugate jointly developed and commercialized by AstraZeneca and Daiichi Sankyo. The companies indicated that regulatory submissions based on DESTINY-Breast05 are also under review in other regions, including the European Union and Japan.
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