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Last reviewed 2026-06-11 · How we verify

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/

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 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
Orserdu	ELACESTRANT	Stemline Therap	Estrogen Receptor Antagonist [EPC]	Estrogen receptor		2023-01-01

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

Stemline Therap · 1 drug in ESR1-mutated advanced or metastatic breast cancer

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

Cite this brief

Drug Landscape (2026). ESR1-mutated advanced or metastatic breast cancer — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/esr1-mutated-advanced-or-metastatic-breast-cancer. Accessed 2026-06-11.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing