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

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

New Capabilities

Antibody-drug conjugate moves into curative-intent treatment for Stage II and III patients

6 days ago: FDA approves two new early-stage indications

Overview

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. The expansion gives doctors a new option before surgery for Stage II and III patients, and a new option 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
Susan Galbraith
Leading AstraZeneca's oncology pipeline; Enhertu is the company's top-selling cancer drug
 Ken Takeshita
Ken Takeshita
Leads R&D at Enhertu's originator company

Organizations Involved

AstraZeneca
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
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
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: 6 days ago
Tap a bar to jump to that date

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

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.

Sources

(5)
AstraZeneca U.S. Food and Drug Administration CURE Today RTT News OncoDaily