FDA approves Enhertu for early-stage HER2-positive breast cancer

Overview

Updated May 18

The U.S. Food and Drug Administration (FDA) cleared AstraZeneca and Daiichi Sankyo's Enhertu for two new uses in early-stage HER2-positive breast cancer in May 2026. The drug, already a standard for advanced disease, now enters the window where the goal is cure, not control.

About one in five breast cancers is HER2-positive, meaning the tumor makes extra copies of a growth-driving protein called human epidermal growth factor receptor 2. Doctors can now use Enhertu before surgery for Stage II and III patients. It can also be used after surgery for those whose tumors survived initial treatment.

Why it matters

Roughly 50,000 American women are diagnosed with HER2-positive breast cancer each year. This approval changes what their first treatment will be.

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Key Indicators

67.3%

Pathologic complete response rate

Share of patients with no detectable invasive cancer at surgery after Enhertu-led pre-surgery treatment, versus 56.3% on the prior chemotherapy regimen.

53%

Reduction in recurrence or death risk

DESTINY-Breast05 showed adjuvant Enhertu cut the risk of invasive disease coming back or death by 53% versus Kadcyla, the prior post-surgery standard.

92.4%

Three-year invasive disease-free survival

Share of post-surgery Enhertu patients with no cancer recurrence at three years, versus 83.7% on Kadcyla.

12%

Interstitial lung disease rate

Rate of lung inflammation, sometimes fatal, in patients on Enhertu combined with pertuzumab. The drug carries a boxed warning.

2,562

Patients across both trials

DESTINY-Breast11 enrolled 927 and DESTINY-Breast05 enrolled 1,635. The largest dataset for an antibody-drug conjugate in early breast cancer.

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People Involved

Susan Galbraith

Executive Vice President, Oncology Research and Development, AstraZeneca

Leading AstraZeneca's oncology pipeline; Enhertu is the company's top-selling cancer drug

Ken Takeshita

Global Head of R&D, Daiichi Sankyo

Leads R&D at Enhertu's originator company

Organizations Involved

AstraZeneca

Pharmaceutical company

Co-commercializes Enhertu with Daiichi Sankyo; lead promoter in the U.S. market

British-Swedish drugmaker that built its oncology franchise around Enhertu and other HER2-targeted therapies.

Daiichi Sankyo

Pharmaceutical company

Originator of trastuzumab deruxtecan; holder of the FDA approval

Japanese drugmaker that invented trastuzumab deruxtecan as DS-8201 and licensed marketing rights to AstraZeneca.

U.S. Food and Drug Administration

Federal regulatory agency

Approved both new indications; also cleared companion diagnostic tests

Federal regulator that reviews and approves drugs for the U.S. market.

Timeline

March 2019 May 2026

5 events Latest: May 18th, 2026 · 3 months ago

Tap a bar to jump to that date

May 2026
FDA approves two new early-stage indications
Latest Regulatory

Enhertu is cleared as pre-surgery therapy for Stage II/III HER2-positive breast cancer and as post-surgery therapy for patients with residual disease after prior treatment.
May 18th, 2026
September 2025
DESTINY-Breast11 readout shows neoadjuvant benefit
Clinical Trial

Pre-surgery Enhertu followed by standard combination produced a 67.3% pathologic complete response rate versus 56.3% for chemotherapy.
September 2025
August 2022
Approval expands to HER2-low metastatic breast cancer
Regulatory

DESTINY-Breast04 results showed Enhertu worked even in patients with low HER2 expression, dramatically expanding the eligible population in metastatic disease.
August 5th, 2022
December 2019
FDA grants accelerated approval for late-stage breast cancer
Regulatory

Enhertu is approved for HER2-positive metastatic breast cancer patients who have had two or more prior anti-HER2 regimens, based on a 60.3% response rate in DESTINY-Breast01.
December 20th, 2019
March 2019
AstraZeneca and Daiichi Sankyo sign $6.9B Enhertu deal
Business

AstraZeneca pays $1.35 billion upfront for global co-development and co-commercialization rights to trastuzumab deruxtecan, then known as DS-8201.
March 28th, 2019

Historical Context

2 moments from history that rhyme with this story — and how they unfolded.

November 2006

Herceptin's adjuvant breakthrough (2006)

The FDA approved Herceptin (trastuzumab) for HER2-positive early breast cancer after data from the HERA, NSABP B-31, and NCCTG N9831 trials showed it cut recurrence by roughly half. Before that, HER2-positive disease was a death sentence for many women diagnosed in their forties and fifties.

Then

Adjuvant Herceptin became standard of care within a year. Genentech's revenue from the drug roughly tripled.

Now

Five-year survival for HER2-positive early breast cancer rose from about 75% to over 90%. Herceptin built the template for targeted cancer therapy.

Why this matters now

Enhertu is following the same path Herceptin took two decades ago: prove benefit in metastatic disease, then move into the curative setting where impact is biggest. The 2006 precedent is what oncologists invoke when they project Enhertu's long-term effect on survival statistics.

May 2019

Kadcyla's residual disease approval (2019)

The FDA approved Kadcyla (trastuzumab emtansine, T-DM1), the first-generation HER2 antibody-drug conjugate, for post-surgery patients with leftover invasive cancer after initial treatment. The KATHERINE trial showed Kadcyla cut recurrence risk by 50% versus continuing Herceptin alone.

Then

Kadcyla became the standard adjuvant therapy for HER2-positive patients with residual disease. Roche's annual Kadcyla revenue passed $2 billion within three years.

Now

The approval validated antibody-drug conjugates as curative-intent therapy and set the comparator that Enhertu had to beat in DESTINY-Breast05.

Why this matters now

Kadcyla is the drug Enhertu directly displaces in the post-surgery setting. The 53% additional risk reduction over Kadcyla in DESTINY-Breast05 is what gave the FDA confidence to approve a more potent, more toxic successor.