ENHERTU Granted Priority Review for HER2 Positive Breast Cancer

The drug will be reviewed as a post-neoadjuvant treatment option in the U.S.

Published on Mar. 9, 2026

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The FDA has granted priority review to ENHERTU, a drug developed by Daiichi Sankyo and AstraZeneca, for use as a post-neoadjuvant treatment for patients with HER2-positive early-stage breast cancer. This accelerates the review process for the drug's potential approval in this indication.

Why it matters

ENHERTU is a targeted therapy that has shown promising results in treating HER2-positive breast cancer, a particularly aggressive form of the disease. Gaining priority review status could lead to faster patient access to this new treatment option if approved.

The details

ENHERTU is an antibody-drug conjugate that delivers a chemotherapy payload directly to HER2-expressing cancer cells. The priority review is based on results from the DESTINY-Breast05 trial, which evaluated ENHERTU as a post-neoadjuvant treatment for patients with HER2-positive early-stage breast cancer who had residual invasive disease after initial treatment.

  • ENHERTU was granted priority review by the FDA on March 9, 2026.

The players

Daiichi Sankyo

A Japanese pharmaceutical company that co-developed ENHERTU with AstraZeneca.

AstraZeneca

A British-Swedish multinational pharmaceutical and biotechnology company that co-developed ENHERTU with Daiichi Sankyo.

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What’s next

If approved, ENHERTU would provide a new treatment option for patients with HER2-positive early-stage breast cancer who have residual disease after initial therapy.

The takeaway

The priority review designation for ENHERTU highlights the significant unmet need for new targeted therapies to treat aggressive forms of breast cancer and could lead to faster patient access if the drug is ultimately approved.