WILMINGTON, DE — The U.S. Food and Drug Administration has accepted and granted Priority Review to a supplemental application for ENHERTU, a breast cancer treatment developed by AstraZeneca and Daiichi Sankyo, for patients with HER2-positive early breast cancer, the companies announced.
The application seeks approval for use in adults with residual invasive disease following initial HER2-targeted therapy before surgery.
The FDA is expected to make a decision in the third quarter of 2026, according to the companies.
The submission is based on results from the Phase III DESTINY-Breast05 trial, which found the drug reduced the risk of invasive disease recurrence or death by 53 percent compared with trastuzumab emtansine, also known as T-DM1.
The trial showed a three-year invasive disease-free survival rate of 92.4 percent for patients treated with ENHERTU, compared with 83.7 percent for those receiving T-DM1.
ENHERTU also reduced the risk of overall disease recurrence or death by 53 percent and lowered the risk of distant recurrence and brain metastases, according to trial data.
The FDA previously granted the treatment Breakthrough Therapy Designation for this use, which is intended to speed development and review of drugs for serious conditions.
The application is also under review through Project Orbis, a program that allows concurrent evaluation of cancer treatments by international regulatory agencies.
Approximately 20 percent of breast cancer cases are classified as HER2-positive, a subtype associated with more aggressive disease.
The companies said about half of patients with early-stage HER2-positive breast cancer continue to have residual disease after initial therapy, increasing the risk of recurrence.
The safety profile observed in the trial was consistent with previous studies, with no new safety concerns identified.
ENHERTU is already approved in more than 90 countries for the treatment of HER2-positive metastatic breast cancer.
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