New Pill for Hormone-Positive Advanced Breast Cancer

Etcamah (camizestrant; Patient Information pronunciation et kam’ ah) is an oral estrogen receptor antagonist. On the USPI it is given as 75 mg film-coated tablets, taken with or without food, swallowed whole (do not cut, crush, or chew; do not take broken tablets). It is labelled only in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for the ESR1-mutation early-switch indication above — not as monotherapy on this label.

Distinct paths — not this carton (fact-only): Other oral endocrine options for ESR1-mutated disease exist under separate labels (for example post-progression oral SERDs, or PROTAC degraders such as labelled vepdegestrant / Veppanu). Those are different molecules, different timing rules, and different labels. Today’s Etcamah door is the AstraZeneca early-switch + CDK4/6 combination label described here (US accelerated; Canada authorised; EU EC MA 20 Jul 2026; Japan エトカマ 19 Jun 2026). Do not treat another ESR1 product’s eligibility or schedule as this carton.

The FDA approved NDA 220359 under accelerated approval on 4 September 2026 (Novel Drug Approvals for 2026 table row 38). Approval letter signed R. Angelo de Claro, MD, Director, Office of Oncologic Diseases (electronic signature LALEH AMIRI KORDESTANI on behalf of ROMEO A DE CLARO, 09/04/2026 03:01:58 PM). NDA dated/received 27 May 2025; major amendment 27 February 2026. Applicant: AstraZeneca Pharmaceuticals LP. Addressee on letter: Ping Hu, PhD, Regulatory Affairs Director. RPM named on letter: Dana Kappel. Dating period on the letter: 36 months from manufacture when stored at 20–25 °C. Reference ID 5864816. Breakthrough therapy designation noted on the FDA oncology notice. Discussed at an Oncologic Drugs Advisory Committee meeting (30 April 2026 per FDA press). Reviewed under Project Orbis with TGA, ANVISA, Health Canada, HSA, and Swissmedic — partner reviews may be ongoing.

Health Canada authorised Etcamah on 4 August 2026 (DPD status Approved; DIN 02570572; PM control 301088; AstraZeneca Canada Inc.).

Where this is taking place

Commercial labelled doors today: United States, Canada, the European Union (EC MA 20 Jul 2026), and Japan (エトカマ錠75mg, 30800AMX00146, 19 Jun 2026).

Other labelled markets and non-labelled regions: European Union — European Commission marketing authorisation 20 July 2026 (EMEA/H/C/006494; EPAR Etcamah). Ask an EU breast oncology clinician for the local SmPC, monitoring, and how to obtain supply; a US bottle is not an EU carton. Japan — エトカマ錠75mg approved 19 June 2026 (approval 30800AMX00146; PMDA RMP / Japanese labelling): 75 mg once daily with a CDK4/6 inhibitor for adults with HR-positive, HER2-negative unresectable or recurrent breast cancer with ESR1 mutation detected during endocrine therapy without disease progression — read the Japanese label. United Kingdom: EMC/PIL materials alone are not a confirmed MHRA marketing-authorisation chip in this draft. TGA ARTG, Swissmedic, ANVISA, and HSA: Project Orbis reviews may be ongoing ≠ licences. Do not import on your own.

SERENA-6 — NCT04964934 (USPI Study) — Phase 3, randomized, double-blind, placebo-controlled, multicenter, ctDNA-guided. Lead sponsor on ClinicalTrials.gov: AstraZeneca. CT.gov status: ACTIVE, NOT RECRUITING. Actual enrolment 315. Countries with listed sites include the United States, Canada, Australia, United Kingdom, Japan, and multiple EU and other countries on the record retrieved for this draft. Expanded access: CT.gov record retrieved for this draft lists hasExpandedAccess: false — no expanded access listed on that record. Not a new-enrolment path for newly labelled commercial use — the pivotal efficacy population that supports the label is already enrolled; follow-up continues (including required final OS reporting).

The practical door in the US or Canada is a breast oncology clinician who can confirm HR+/HER2− advanced disease, document ≥6 months on AI + CDK4/6 without progression (US selection language), arrange FDA-authorized / clinic-appropriate ESR1 ctDNA testing, switch the aromatase inhibitor to Etcamah 75 mg daily while continuing the same CDK4/6 inhibitor, and monitor ECG, heart rate, vision, and blood counts — not treating NCT04964934 as open recruitment.

Approval matrix

Access by country

• United States: Ask a breast medical oncology clinic about FDA-labelled Etcamah. Labelled 4 September 2026 (accelerated) for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer upon ESR1 mutation detection during AI + CDK4/6 inhibitor therapy, in combination with abemaciclib, palbociclib, or ribociclib, based on an FDA-authorized test. Recommended Etcamah dose: 75 mg orally once daily with or without food until progression or unacceptable toxicity. Continue the CDK4/6 inhibitor at the same dosage as when the ESR1 mutation was detected. Strength: 75 mg tablets; 28-count bottle NDC 0310-0075-01. Select patients using plasma ESR1 testing with an FDA-authorized test — USPI describes testing every 3 months until an ESR1 mutation is detected in patients who have received at least 6 months of AI + CDK4/6 therapy. Prior authorisation and specialty-pharmacy logistics still apply. No list price or copay dollars in this article. Suspected adverse reactions: AstraZeneca 1-800-236-9933 or FDA MedWatch 1-800-FDA-1088. This is US commercial labelled supply, not a DIY import. Accelerated approval means confirmatory benefit (including overall survival maturity) is still required.

• Canada: Ask a Canadian medical oncology clinic about Health Canada–authorised Etcamah. DPD Approved 4 August 2026; DIN 02570572; PM control 301088. Canadian indication: combination with a CDK4/6 inhibitor for adults with HR+/HER2− locally advanced or metastatic breast cancer upon ESR1m detection during first-line AI-based endocrine therapy. Use the Canadian Product Monograph for Canadian prescribing details. Authorized is not funded.

• European Union: EC marketing authorisation 20 July 2026 (EMEA/H/C/006494). Ask a breast oncology clinician in your member state for labelled Etcamah + CDK4/6 access under the EU SmPC, local reimbursement, and ESR1 testing rules. A US or Canadian carton is not the EU care plan.

• Japan: エトカマ錠75mg approved 19 June 2026 (30800AMX00146). Ask a Japanese breast oncology clinician for labelled access under the Japanese 添付文書 (75 mg QD + CDK4/6; ESR1m during endocrine therapy without progression). A US/EU/Canadian carton is not the Japanese care plan.

• United Kingdom: Soft only — EMC/PIL materials are not treated here as a confirmed MHRA marketing-authorisation chip. Ask a UK clinician what legal paths exist.

• Australia / Brazil / Singapore / Switzerland / other countries: TGA, ANVISA, HSA, Swissmedic: Project Orbis ongoing review ≠ licence. Trial participation is not a commercial Etcamah label.

• If your regulator has not authorised it: do not import on your own. Ask the local oncology clinician about documented special-access / named-patient rules, referral to a centre in a labelled country, or waiting — without treating a US or Canadian bottle as a foreign carton.

Who is eligible (from the US label; Canada uses the PM)

This is an adult HR+/HER2− advanced breast cancer conversation — ESR1 detected during AI + CDK4/6 therapy — used with a CDK4/6 inhibitor, not a front-line Etcamah monotherapy label and not a paediatric label.

United States (USPI / Patient Information, revised / issued September 2026):

• Indication: Etcamah in combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for adult patients with HR-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test. Accelerated approval based on PFS from ESR1 detection; continued approval may require confirmatory trial(s).
• Patient selection: At least 6 months of AI + CDK4/6 therapy; ESR1 mutation in plasma using an FDA-authorized test (USPI describes testing every 3 months until detected). Companion diagnostic information: FDA Companion Diagnostics page; Guardant360 CDx authorized with this approval.
• Recommended dosage: Etcamah 75 mg orally once daily, with or without food, until progression or unacceptable toxicity. Administer with a CDK4/6 inhibitor; continue CDK4/6 at the same dosage as when ESR1 was detected.
• Swallow whole. Take at approximately the same time each day.
• Missed dose: If missed within 6 hours, take; if missed more than 6 hours, skip — take next dose at usual time. If vomited, do not take an extra dose.
• No Etcamah dose reductions recommended on the USPI modification table (withhold / resume / permanently discontinue rules apply for QTc, bradycardia, visual disturbances, and other Grade ≥3 ARs).
• Cardiac evaluation: ECG prior to initiation, then every week for the first 2 weeks, and periodically as clinically indicated. Monitor heart rate more frequently in the first 30 days if baseline bradycardia (<60 bpm) or on heart-rate–lowering drugs.
• Contraindications: None (USPI §4).
• Hepatic impairment: For severe (Child-Pugh C) hepatic impairment with ribociclib, Etcamah 75 mg every other day; with abemaciclib or palbociclib, no Etcamah dose change recommended — monitor.
• Pregnancy / contraception: Can cause fetal harm. Females of reproductive potential: effective non-hormonal contraception during treatment and for 4 weeks after the last dose. Males with female partners of reproductive potential: effective contraception during treatment and for 1 week after the last dose (and follow the longest window required by the co-administered CDK4/6 inhibitor, including palbociclib when used).
• Lactation: Advise not to breastfeed during treatment and for 1 week after the last dose.
• Pediatrics: Safety and effectiveness not established.

Canada (Product Monograph, authorised 4 August 2026 — high level):

• Indicated in combination with a CDK4/6 inhibitor for adults with HR+/HER2− locally advanced or metastatic breast cancer upon ESR1m detection during first-line AI-based endocrine therapy.
• Contraindication includes hypersensitivity to camizestrant or any formulation ingredient (Canadian PM wording).
• Ask the clinic to follow the Canadian PM for Canadian dosing, monitoring, and counselling details.

Not labelled on sources confirmed for this draft:

• Children / adolescents.
• UK, Australian, Swiss, Brazilian, or Singaporean Etcamah marketing authorisations (not confirmed as chips here; Orbis ongoing review ≠ licence).
• Etcamah monotherapy on the USPI / Canadian PM combination indication.
• Using Etcamah as a substitute for a different ESR1-directed product’s label.
• Treating SERENA-6 follow-up as open commercial enrolment.

What the pivotal study showed (SERENA-6 / USPI)

Use the USPI (US) or Canadian Product Monograph (Canada) for a prescription conversation. Journals and conference abstracts are supportive reading.

SERENA-6 — NCT04964934:

• Randomized 1:1, double-blind, placebo-controlled, multicenter; 315 adults with ER-positive, HER2-negative locally advanced or metastatic breast cancer with detectable ESR1 mutations; currently on AI + CDK4/6 for ≥6 months as initial endocrine-based treatment without disease progression; ESR1 assessed by Guardant360 CDx ctDNA testing.
• Arms: Etcamah 75 mg daily + CDK4/6 (n=157) versus continued AI (anastrozole or letrozole) + CDK4/6 (n=158). CDK4/6 choice/dose unchanged at randomisation (palbociclib 76%, ribociclib 15%, abemaciclib 10% in the randomised population described on the USPI).
• Primary endpoint: investigator-assessed PFS (RECIST 1.1). Additional: OS (immature at PFS analysis — 39 events, 12% maturity).

USPI Table 8 (efficacy):

Trial-status honesty: SERENA-6 supports the US accelerated label and informs the Canadian authorisation narrative. CT.gov remains ACTIVE, NOT RECRUITING because follow-up continues — that is not a door for new commercial starters outside labelled US / Canadian / EU / Japanese distribution. FDA PMR 5047-2 requires final OS from SERENA-6 (timetable: trial completion 09/2028, final report 12/2028). No expanded access is listed on the CT.gov record retrieved for this draft.

How it is taken (US label — keep this exact)

Safety (what the label puts first)

Boxed warning — Arrhythmia risk with concomitant QTc-prolonging drugs: Etcamah with ribociclib (a QTc-prolonging drug and strong CYP3A inhibitor) or with other QTc-prolonging drugs can increase risk of Torsades de Pointes, other ventricular arrhythmias, and sudden death. Avoid other QTc-prolonging products when possible; if unavoidable, monitor QTc more frequently. Obtain ECG before start; monitor heart rate and QTc; correct electrolytes.

Bradycardia: Monitor heart rate more frequently in the first 30 days when baseline HR <60 bpm or on heart-rate–lowering drugs. Withhold / permanently discontinue based on severity.

Embryo-fetal toxicity: Contraception windows as above (4 weeks after last dose for females with non-hormonal contraception; 1 week for males — and respect CDK4/6 inhibitor windows).

Most common adverse reactions (≥20%, including laboratory abnormalities) with Etcamah + CDK4/6: decreased neutrophils, decreased leukocytes, decreased hemoglobin, decreased lymphocytes, decreased platelets, visual disturbances, and fatigue.

Selected Table 2 rates (Etcamah + CDK4/6, N=155): visual disturbances 34%; fatigue 23%; dry eye 12%; arthralgia 16%; nausea 10%.

Selected Table 3 lab rates (Etcamah + CDK4/6): neutrophils decreased 68% (Grade 3/4 42%); leukocytes decreased 66%; hemoglobin decreased 47%; lymphocytes decreased 39%; platelets decreased 36%.

Serious ARs: 10%. Fatal ARs 1.3% (ARDS and sudden death 0.6% each). Permanent discontinuation of Etcamah 1.3%. Dosage interruptions 22% (bradycardia 3.9%, visual disturbances 2.6% among ≥2%).

Drug interactions (high level): Monitor / modify with strong CYP3A inhibitors; avoid strong CYP3A inducers; moderate CYP3A inducer rules differ by CDK4/6 partner (may require Etcamah 150 mg daily with abemaciclib or palbociclib if unavoidable). Avoid CYP2C9 / CYP2C19 substrates unless otherwise recommended. QTc-prolonging drugs and bradycardia-causing drugs require special caution.

Report suspected adverse reactions to AstraZeneca 1-800-236-9933 or FDA MedWatch 1-800-FDA-1088.

How to talk to a doctor

Bring the brand, the INN, the NDA / DIN / NCT numbers, and the US Prescribing Information or Canadian Product Monograph for your country.

1. “I am an adult with HR-positive, HER2-negative locally advanced or metastatic breast cancer on an aromatase inhibitor + CDK4/6 inhibitor. Has my blood been tested for an ESR1 mutation with an authorised test?”
2. “The FDA gave accelerated approval to Etcamah (camizestrant) on 4 September 2026, and Health Canada authorised it on 4 August 2026. Is that labelled for me in this country?”
3. “The labelled Etcamah dose is 75 mg by mouth once daily with or without food, with continued CDK4/6 at the same dose as when ESR1 was found. How will we switch off the aromatase inhibitor and monitor ECGs?”
4. “SERENA-6 (NCT04964934) showed median PFS 16.0 vs 9.2 months (HR 0.44). Overall survival was not mature. What does accelerated approval / confirmatory follow-up mean for my plan?”
5. “Please cover the boxed QTc / arrhythmia warning — especially if I am on ribociclib — and bradycardia symptoms.”
6. “Please cover visual disturbances / blurred vision and when to see eye care.”
7. “I am not asking about a different ESR1 product’s label — only this Etcamah early-switch + CDK4/6 combination.”
8. “Please plan pregnancy testing and non-hormonal contraception during treatment and for 4 weeks after if I can become pregnant; advise male partners’ windows and breastfeeding rules.”
9. “Please review my other medicines for CYP3A / CYP2C9 / CYP2C19 and QTc interactions.”
10. “Is prior authorisation started? Who coordinates the 75 mg bottles (for example NDC 0310-0075-01 / Canadian DIN 02570572)?”
11. “Etcamah is labelled in the US, Canada, EU (EC MA 20 Jul 2026), and Japan (エトカマ錠75mg, 19 Jun 2026). UK is not chipped here yet. Orbis ongoing review is not a licence. I will not import a foreign carton.”

Research and regulatory team (from sources only — no invented contacts)

Names and roles as they appear on primary sources — not a clinic directory.

• AstraZeneca Pharmaceuticals LP, Wilmington, DE 19850 — NDA 220359 applicant; USPI “Distributed by”; AE line 1-800-236-9933.
• AstraZeneca Canada Inc., Mississauga, ON — Health Canada DIN 02570572 / PM holder.
• AstraZeneca — ClinicalTrials.gov lead sponsor for NCT04964934.
• Ping Hu, PhD — AstraZeneca Regulatory Affairs Director — addressee on the NDA approval letter (corporate regulatory contact, not a treating clinic).
• Dana Kappel — FDA Regulatory Project Manager named on the approval letter.
• R. Angelo de Claro, MD — Director, Office of Oncologic Diseases — signed the 4 September 2026 approval letter.
• Site-level hospital phone numbers are not listed here — ask your own breast oncology clinician.

Canada zoom: Etcamah authorised

Health Canada status Approved (2026-08-04); DIN 02570572; Product Monograph control 301088; AstraZeneca Canada Inc. Canadian labelled use is combination with a CDK4/6 inhibitor upon ESR1m detection during first-line AI-based endocrine therapy. US FDA accelerated approval does not replace the Canadian PM. Ask a Canadian medical oncology clinician about testing, prescribing, monitoring, and funding pathways under the Canadian label. Authorized is not funded.

Bottom line

Etcamah (camizestrant) is an oral estrogen receptor antagonist labelled with a CDK4/6 inhibitor for adults with HR-positive, HER2-negative locally advanced or metastatic breast cancer after ESR1 mutation detection on aromatase-inhibitor–based therapy. FDA accelerated approval 4 September 2026 (NDA 220359); Health Canada authorised 4 August 2026 (DIN 02570572). Dose: 75 mg by mouth once daily; continue the same CDK4/6 inhibitor. SERENA-6 (NCT04964934) showed median PFS 16.0 vs 9.2 months (HR 0.44); OS immature. Watch QTc / arrhythmia (boxed), bradycardia, visual disturbances, cytopenias, and pregnancy. US + Canada + EU + Japan labelled (EC MA 20 Jul 2026, EMEA/H/C/006494; Japan エトカマ錠75mg 30800AMX00146, 19 Jun 2026). Orbis partner ongoing reviews ≠ licences; UK not chipped (EMC/PIL soft only). The door is a breast oncology clinic writing the labelled combination after authorised ESR1 testing — pivotal follow-up is not a new commercial enrolment path. Authorized is not funded.

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Primary sources

1. EMA EPAR Etcamah (EMEA/H/C/006494; EC MA 20 Jul 2026) — https://www.ema.europa.eu/en/medicines/human/EPAR/etcamah 0b. PMDA RMP — エトカマ錠75mg (approval 30800AMX00146; 19 Jun 2026) — https://www.pmda.go.jp/RMP/www/670227/fcb27025-779c-4930-b4a0-c3024ee02fbd/670227_42910J6F1020_001RMP.pdf
2. FDA Novel Drug Approvals for 2026 — Etcamah / camizestrant, approval date 9/4/2026, row 38 — https://www.fda.gov/drugs/novel-drug-approvals-fda/novel-drug-approvals-2026
3. FDA oncology accelerated-approval notice — camizestrant with a CDK4/6 inhibitor for ESR1-mutated HR+/HER2− advanced breast cancer — https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-camizestrant-cdk46-inhibitor-esr1-mutated-hr-positive-her2-negative
4. FDA press announcement — FDA Grants Accelerated Approval to a New Breast Cancer Treatment — 4 Sep 2026 — https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-new-breast-cancer-treatment
5. FDA Prescribing Information PDF, NDA 220359, Reference ID 5864816 — https://www.accessdata.fda.gov/drugsatfda_docs/label/2026/220359Orig1s000lbl.pdf
6. FDA NDA approval letter, NDA 220359, signed R. Angelo de Claro, MD, 4 September 2026 — https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2026/220359Orig1s000ltr.pdf
7. ClinicalTrials.gov NCT04964934 — SERENA-6 — https://clinicaltrials.gov/study/NCT04964934
8. Health Canada DPD — Etcamah DIN 02570572, status Approved 2026-08-04 — https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=107271
9. Health Canada Product Monograph PDF (control 301088) — https://pdf.hres.ca/dpd_pm/00085663.PDF