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AstraZeneca, Daiichi Sankyo File for FDA Enhertu Approval in Second-Line HER2-Postive Breast Cancer

NEW YORK – AstraZeneca and Daiichi Sankyo on Monday said the US Food and Drug Administration has accepted their supplemental biologics application for trastuzumab deruxtecan (Enhertu; T-DXd) as a treatment for advanced HER2-positive breast cancer patients after prior HER2-targeted treatment.

The agency will review the application in an expedited manner under the priority review and real-time oncology review frameworks and issue a decision during the second quarter of 2022.

The companies submitted data from the DESTINY-Breast03 trial in which investigators pitted Daiichi Sankyo and AstraZeneca's antibody-drug conjugate against Genentech's trastuzumab emtansine (Kadcyla; T-DM1).

Researchers presented results from this study at the European Society for Medical Oncology's meeting in September and reported that T-DXd reduced patients' risk of disease progression or death by 72 percent compared to T-DM1. More than 94 percent of T-DXd-treated patients were alive at one year, versus 85.9 percent of T-DM1-treated patients. The objective response rates were 79.7 percent and 34.2 percent, respectively, in the T-DXd and T-DM1 treatment arms.

T-DXd is already approved in the US for HER2-positive advanced breast cancer patients who have received two or more HER2-targeted treatment regimens. If the FDA approves this new application, it would allow oncologists to prescribe T-DXd in earlier treatment lines.

According to a statement from Ken Takeshita, Daiichi Sankyo's global head of R&D, this is the first time a drug application will have undergone both priority review and real-time oncology review simultaneously.

"The FDA's prioritization of our application underscores the potential of this medicine and the continued need to expedite the availability of new treatment options, while making it possible to potentially receive approvals in several countries concurrently," Takeshita said.