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Last reviewed 2026-06-10 · How we verify

ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer — Treatment Landscape & Competitive Intelligence

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer (disease) competitive landscape: 1 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

1 marketed 0 Phase 3 0 Phase 2 Live · 30-min refresh

Marketed treatment landscape

Approved drugs treating ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer, deduplicated by molecule. See the full disease page for line-of-therapy detail.

Drug	Generic	Sponsor	Class	Target	Line of therapy	First approval
Inluriyo	IMLUNESTRANT	Eli Lilly And Co	Estrogen Receptor Antagonist [EPC]			2025-01-01

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this treatment set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this treatment set.

Sponsor landscape

Eli Lilly And Co · 1 drug in ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer

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Every new regulatory action, PDUFA date, or trial completion in ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer:

Cite this brief

Drug Landscape (2026). ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/er-positive-her2-negative-esr1-mutated-advanced-or-metastatic-breast-cancer. Accessed 2026-06-10.

ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer full disease profile — treatment pathway, diagnostics, guidelines
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing