FDA has accepted the supplemental Biologics License Application (sBLA) for Enhertu (trastuzumab deruxtecan), a HER2-directed antibody and DNA topoisomerase I inhibitor conjugate from AstraZeneca (LON:AZN) and Daiichi Sankyo (OTCMKTS:DSNKY).
The sBLA pertains to treating adults with unresectable or metastatic HER2-positive breast cancer previously treated with an anti-HER2-based regimen.
FDA also granted priority review to the application.
In 2019, Enhertu first won FDA approval for HER2-positive unresectable or metastatic breast cancer after two or more prior anti-HER2-based regimens.
Two years later, the agency extended approval to patients with previously-treated HER2-positive advanced gastric cancer.
The recent application includes data from the DESTINY-Breast03 study,
That study found that Enhertu demonstrated a statistically significant improvement in progression-free survival compared with trastuzumab emtansine (T-DM1) (Kadcyla…