Enhertu

Enhertu | AstraZeneca Intelligence | Humanexa

Regulatory Timeline

FDA, EMA, PMDA, and other regulatory milestones from linked signals and precedents.

FDAJun 8, 2026approval
Competitive Generic Therapy Approvals
Explore the FDA’s Competitive Generic Therapy Approvals page, offering insights into the program designed to encourage generic drug competition. Access information about approved CGT products and find resources, including a downloadable CGT approvals spreadsheet.
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FDAJun 8, 2026approval
FDA Drug Competition Action Plan | Improving the efficiency of the generic drug development, review, and approval process
By clarifying FDA’s regulatory expectations for new entrants and experienced drug developers alike, FDA is supporting prospective generic drug developers and improving the overall quality of ANDAs submitted to the Agency for approval.
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PMDAJun 8, 2026approval
[SHINSA]English Translation of Review Report: Blenrep, Neffy, and Tecentriq (Partial Change Approval)
PMDA document relevant to the signal.
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FDAJun 8, 2026safety_guidance
FDA AP — ENHERTU (SUPPL)
Application BLA761139. Sponsor: DAIICHI SANKYO. Submission status: AP. Submission type: SUPPL. Review priority: PRIORITY. Active ingredients: FAM-TRASTUZUMAB DERUXTECAN-NXKI.
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FDAJun 8, 2026safety_guidance
Novel Drug Approvals for 2026
Novel Drug Approvals for 2026
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FDAJun 16, 2026approval
FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer
Why this matters: sets a approval precedent in the same sub-indication (her2) as AstraZeneca; the same agency is already in play for this signal, so precedent weight is higher.
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FDAJun 16, 2026approval
FDA Drug Competition Action Plan | Improving the efficiency of the generic drug development, review, and approval process
By clarifying FDA’s regulatory expectations for new entrants and experienced drug developers alike, FDA is supporting prospective generic drug developers and improving the overall quality of ANDAs submitted to the Agency for approval.
View detail
FDAJun 16, 2026approval
Oncology (Cancer)/Hematologic Malignancies Approval Notifications
FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products.
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AstraZenecaJun 16, 2026mid-term
Enhertu Gains FDA Approval for Two New HER2+ Early Breast Cancer Indications
The approval represents a critical regulatory milestone that validates Enhertu's efficacy in new settings, which may prompt further regulatory scrutiny and opportunities for additional indications.
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Evidence Sources

Source-backed references used to construct this page.

FDA AP — ENHERTU (SUPPL)
FDA
FDA document
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FDA AP — ENHERTU (SUPPL)
FDA
FDA document
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FDA AP — PHESGO (SUPPL)
FDA
FDA document
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FDA AP — HERCEPTIN (SUPPL)
FDA
FDA document
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FDA AP — ONTRUZANT (SUPPL)
FDA
FDA document
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FDA AP — ONTRUZANT (SUPPL)
FDA
FDA document
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FDA AP — HERCEPTIN HYLECTA (SUPPL)
FDA
FDA document
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FDA AP — HERCEPTIN (SUPPL)
FDA
FDA document
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Adding an Immunotherapy Drug, MEDI4736 (Durvalumab), to the Usual Chemotherapy Treatment (Paclitaxel, Cyclophosphamide, and Doxorubicin) for Stage II-III Breast Cancer
ClinicalTrials.gov
FDA document
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RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive
ClinicalTrials.gov
FDA document
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Unintentional Weight Loss and Cancer: A Prospective Trial of Patient-centered Weight Tracking Combined With GRAIL Galleri Testing to Improve Early Detection
ClinicalTrials.gov
FDA document
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STARD10 promotes progression of HER2+ breast cancer and intracellular lipid metabolism via the cAMP/PKA/CREB1 signaling axis.
PubMed
FDA document
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Trial watch: antibody-drug conjugates in cancer therapy.
PubMed
FDA document
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Anticancer activity of fluoxetine Janus dendrimer against cancer cells.
PubMed
FDA document
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Enhertu Gains FDA Approval for Two New HER2+ Early Breast Cancer Indications
AstraZeneca
FDA document
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Enhertu approved in two HER2+ early BC settings
Cision
FDA document
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Enhertu recommended for EU approval in HER2+ metastatic solid tumours
AstraZeneca
FDA document
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FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer
FDA
FDA document
View source
FDA Drug Competition Action Plan | Improving the efficiency of the generic drug development, review, and approval process
FDA
FDA document
View source
Oncology (Cancer)/Hematologic Malignancies Approval Notifications
FDA
FDA document
View source

Enhertu

Asset Overview

Company Context

Regulatory Timeline

Competitive Generic Therapy Approvals

FDA Drug Competition Action Plan | Improving the efficiency of the generic drug development, review, and approval process

[SHINSA]English Translation of Review Report: Blenrep, Neffy, and Tecentriq (Partial Change Approval)

FDA AP — ENHERTU (SUPPL)

Novel Drug Approvals for 2026

FDA approves capivasertib with abiraterone and prednisone for PTEN-deficient androgen pathway modulation-naïve or -sensitive prostate cancer

FDA Drug Competition Action Plan | Improving the efficiency of the generic drug development, review, and approval process

Oncology (Cancer)/Hematologic Malignancies Approval Notifications

Enhertu Gains FDA Approval for Two New HER2+ Early Breast Cancer Indications

Related Signals

Portfolio Development

Evidence Sources