# ENHERTU (fam-trastuzumab deruxtecan-nxki) PDUFA Event: HER2-positive early breast cancer with residual invasive disease after neoadjuvant therapy

Canonical URL: https://biopharmsignal.com/pdufa-calendar/AZN/enhertu-post-neoadjuvant-her2-positive-early-breast-cancer

Ticker: AZN

Company: AstraZeneca PLC

Event date: 2026-07-07

Event type: FDA Decision

Stage: PDUFA

Result: Approved

Result date: 2026-05-15

Application type: sBLA

FDA approved ENHERTU for post-neoadjuvant treatment. FDA approved ENHERTU as adjuvant treatment for adults with HER2-positive early breast cancer who have re...

## Event Timeline

### May 15, 2026 — FDA approved ENHERTU for post-neoadjuvant treatment

FDA approved ENHERTU as adjuvant treatment for adults with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant trastuzumab with or without pertuzumab and taxane-based treatment. The action occurred before the July 7 PDUFA date.

[FDA — ENHERTU approvals in HER2-positive early-stage breast cancer](https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-two-separate-indications-fam-trastuzumab-deruxtecan-nxki-her2-positive-early-stage)

### March 9, 2026 — FDA accepted the sBLA with Priority Review

FDA accepted the post-neoadjuvant sBLA, granted Priority Review and assigned a July 7, 2026 PDUFA date. The application was also reviewed under Project Orbis.

[Daiichi Sankyo — sBLA acceptance and Priority Review](https://www.daiichisankyo.com/files/news/pressrelease/pdf/202603/20260309_E.pdf)

### December 22, 2025 — FDA granted Breakthrough Therapy designation

FDA granted Breakthrough Therapy designation for ENHERTU as post-neoadjuvant therapy in HER2-positive early breast cancer based on DESTINY-Breast05.

[Daiichi Sankyo — Breakthrough Therapy designation](https://www.daiichisankyo.com/files/news/pressrelease/pdf/202512/20251222_E2.pdf)

### October 18, 2025 — Detailed DESTINY-Breast05 results were reported

DESTINY-Breast05 showed a 53% reduction in the risk of invasive disease recurrence or death with ENHERTU versus T-DM1, with a three-year invasive disease-free survival rate of 92.4% versus 83.7%.

[Daiichi Sankyo — Detailed DESTINY-Breast05 results](https://www.daiichisankyo.com/files/news/pressrelease/pdf/202510/20251018_E4.pdf)

### September 29, 2025 — DESTINY-Breast05 met its primary endpoint

The Phase 3 trial demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival versus T-DM1 in patients with residual invasive disease after neoadjuvant therapy.

[Daiichi Sankyo — Positive DESTINY-Breast05 topline results](https://www.daiichisankyo.com/files/news/pressrelease/pdf/202509/20250929_E.pdf)

### November 2, 2020 — DESTINY-Breast05 was initiated

Daiichi Sankyo and AstraZeneca initiated the global Phase 3 head-to-head trial of ENHERTU versus T-DM1 in high-risk HER2-positive early breast cancer after neoadjuvant therapy.

[Daiichi Sankyo — DESTINY-Breast05 trial initiation](https://www.daiichisankyo.com/media/press_release/detail/index_4088.html)

## Regulatory Designations

- Priority Review FDA: [Daiichi Sankyo — Priority Review and July 7 PDUFA date](https://www.daiichisankyo.com/files/news/pressrelease/pdf/202603/20260309_E.pdf)

- Breakthrough Therapy FDA: [Daiichi Sankyo — Breakthrough Therapy designation for post-neoadjuvant ENHERTU](https://www.daiichisankyo.com/files/news/pressrelease/pdf/202512/20251222_E2.pdf)

## Related Pages

- AZN PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/AZN.md

- AZN company profile: https://biopharmsignal.com/company/AZN.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

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