medcelerator · clinician one-pager
New Pill for Hormone-Positive Advanced Breast Cancer
Etcamah (camizestrant) — oral ER antagonist with CDK4/6 for ESR1m HR+/HER2− advanced breast cancer
Health Canada/FDA Approved · United States, Canada, Japan, European Union · September 11, 2026
Condition: Breast Cancer
Who this is for
This is for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer who are already on an aromatase inhibitor plus a CDK4/6 inhibitor and whose blood ctDNA test shows an ESR1 mutation before imaging progression — and who may be candidates for labelled Etcamah switched onto the same CDK4/6 backbone. It explains the US accelerated label, the Canadian Product Monograph route, the EU EC marketing authorisation (20 July 2026), and the Japanese エトカマ錠75mg approval (19 June 2026), the SERENA-6 progression-free survival numbers, QTc / bradycardia / visual-disturbance watchpoints, how the once-daily 75 mg tablet works with continued CDK4/6 therapy, and how to talk with a breast oncology clinician — without treating an Orbis partner review or a DIY import as the care plan. Authorized is not funded.
Next clinical step
Health Canada and the US Food and Drug Administration (FDA) have approved this medicine. In Canada, the United States and the European Union, ask your doctor or a specialist whether it suits you. They can write a prescription. Insurance or public drug plan coverage is not guaranteed. In Canada, it is authorised but may not be on sale yet. In Japan, authorisation is not confirmed; see Possible routes below if any are listed.
Ways to access this treatment
United States · Prescription
US prescription (FDA-labelled)
https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220359Orig1s000lbl.pdf
European Union · Prescription
EU prescription (EC marketing authorisation)
https://www.ema.europa.eu/en/medicines/human/EPAR/etcamah
United States, European Union · Recruiting clinical trial
A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer
Tests this treatment. Camizestrant plus a CDK4/6 inhibitor (ribociclib) in ER+/HER2- advanced breast cancer, as in the label (phase 3b).
https://clinicaltrials.gov/study/NCT07647328
European Union · Recruiting clinical trial
Efficacy and Safety of Camizestrant Plus Ribociclib in Patients With Breast Cancer
Tests this treatment. Camizestrant plus ribociclib in HR+ breast cancer (phase 2).
https://clinicaltrials.gov/study/NCT07195227
United States, European Union, Japan, Canada · Recruiting clinical trial
A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy
Combination or different setting. Early breast cancer after adjuvant endocrine therapy; the label is advanced ESR1-mutated disease (phase 3).
https://clinicaltrials.gov/study/NCT05774951
Search all trials on ClinicalTrials.gov: https://clinicaltrials.gov/search?cond=breast%20cancer&intr=camizestrant&aggFilters=status:rec
Search Health Canada's Clinical Trials Search Portal: https://clinical-trials-search.canada.ca/en/search?search_api_fulltext=camizestrant
Possible routes (not confirmed)
Canada · Prescription · Applicability unknown
Canada prescription (Health Canada NOC, DIN 02570572)
Health Canada issued a Notice of Compliance (NOC) on 2026-08-04 (DIN 02570572), but the Drug Product Database does not list it as marketed yet; Canadian supply date not confirmed.
https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=107271
General resources for further research
Canadian Cancer Trials Group
A national network conducting clinical trials for cancer treatment. Patients can search for trials by cancer type and location.
https://www.ctg.queensu.ca/
Canadian Clinical Trial Search Portal (Health Canada)
Health Canada's public search of the drug and biologic clinical trials it has authorised in Canada (phase 1 to 3, since April 2013). Search by condition, drug, or trial status and see where trials are running. It replaced the Health Canada Clinical Trials Database in July 2026. A listing is not enrolment, and Health Canada does not recruit patients: ask your clinician and contact the trial sponsor.
https://clinical-trials-search.canada.ca/en/home
ClinicalTrials.gov
US National Library of Medicine registry of clinical studies. Search by condition, drug, NCT number, and location. A listing is not enrolment, eligibility, or funding. Talk with the trial contact and a clinician before assuming a slot exists.
https://clinicaltrials.gov/
CTIS (EU Clinical Trials Information System)
European Union public portal for clinical trials submitted under the Clinical Trials Regulation. Search by medicine, condition, and member state. A CTIS record is not an EMA marketing authorisation and is not enrolment.
https://euclinicaltrials.eu/
jRCT (Japan Registry of Clinical Trials)
Japan Registry of Clinical Trials, the public registry used under Japanese clinical-trial rules. Search studies by condition and location. A jRCT listing is not PMDA approval and is not enrolment.
https://jrct.mhlw.go.jp/en-top
AI-produced discussion aid; not prescribing instructions. Approval does not establish coverage. Full article: https://medcelerator.com/articles/etcamah-camizestrant