Data updated: Nov 8, 2026
ETCAMAH (camizestrant) · AstraZeneca
Approved 2026-09-04
1
Indication
--
Phase 3 Trials
0
Years on Market
Details
- Status
- Prescription
- First Approved
- 2026-09-04
- Revenue
- $7M (Q3-2026)
- Routes
- ORAL
- Dosage Forms
- TABLET
Latest ETCAMAH News
All ETCAMAH news →- AstraZeneca results: 9M and Q3 2026 Continued strong commercial performance and 12 positive Phase III programme readouts in the year to dat e ↗
- Update on SERENA-4 Phase III trial of Etcamah in combination with palbociclib in upfront 1st-line advanced ER-positive breast cancer ↗
- Etcamah in combination with a CDK4/6 inhibitor approved in the US for 1st-line advanced HR-positive breast cancer ↗
ETCAMAH Approval History
Original
New Indication
New Form
Label Update
1 FDA actions from 2026 to 2026
What ETCAMAH Treats
1 FDA approvalsOriginally approved for its first indication in 2026 .
- Other (1)
AstraZeneca's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
TRUQAP
2023 CAPIVASERTIB
3 designations
BEYFORTUS
2023 NIRSEVIMAB-ALIP
1 designation
WAINUA (AUTOINJECTOR)
2023 EPLONTERSEN SODIUM
1 designation
IMJUDO
2022 TREMELIMUMAB-ACTL
1 designation
SAPHNELO
2021 ANIFROLUMAB-FNIA
2 designations
TEZSPIRE
2021 TEZEPELUMAB-EKKO
2 designations
KOSELUGO
2020 SELUMETINIB
4 designations
LOKELMA
2018 SODIUM ZIRCONIUM CYCLOSILICATE
CALQUENCE
2017 ACALABRUTINIB MALEATE
4 designations
FASENRA
2017 BENRALIZUMAB
IMFINZI
2017 DURVALUMAB
3 designations
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Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06188520 CYCAD-1 | D8470C00001 2023-507305-33-00, 2023 | Ph 1, Ph 2 | active not recruiting | A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With Selected Advanced or Metastatic Solid Tumors |
| NCT05774951 CAMBRIA-1 | D8531C00002 2022-501024-20-00 | Ph 3 | recruiting | A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy |
| NCT06380751 EvoPAR-BR01 | D9722C00001 | Ph 3 | recruiting | Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer |
| NCT07427394 SERENA-1b | D853CC00001 | Ph 2 | recruiting | Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer |
| NCT04644068 PETRA | D9720C00001 2020-002688-77 | Ph 1, Ph 2 | active not recruiting | Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies |
| NCT07195227 CADILLAC | MEDOPP555 | Ph 2 | recruiting | Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Breast Cancer |
| NCT06547164 | D8532C00006 | Ph 1 | completed | A Study to Investigate the Pharmacokinetics of Midazolam After Repeated Doses of Camizestrant (AZD9833) and to Investigate the Pharmacokinetics of Camizestrant When Administered Alone and in Combination With Carbamazepine in Healthy Post-Menopausal Female Participants |
| NCT05952557 CAMBRIA-2 | D8535C00001 2023-504031-41-00 | Ph 3 | active not recruiting | An Adjuvant Endocrine-based Therapy Study of Camizestrant (AZD9833) in ER+/HER2- Early Breast Cancer (CAMBRIA-2) |
| NCT05790304 | D8532C00002 2022-502277-41-00 | Ph 1 | completed | Study to Investigate Hepatic Impairment on PK, Safety, Tolerability of Camizestrant in Post-Menopausal Female Subjects |
| NCT05551897 | D8532C00003 2022-002011-35 | Ph 1 | completed | A Study to Assess the Pharmacokinetics of Camizestrant (AZD9833) When Administered Alone and in Combination With Itraconazole |
| NCT07647328 SERAFA-1 | D8532C00008 | Ph 3 | recruiting | A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer |
| NCT07840443 CARA | OZUHN-050 | Ph 2 | not yet recruiting | Phase II Study of CAmizestrant in Resectable Endometrial Adenocarcinoma |
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ETCAMAH FDA Label Details
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Revenue Insights
- • Q3-2026: $7M
- • Historical trend analysis
Patent Timeline
- • Patent expiration dates
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.