{"entity":{"id":"camizestrant","kind":"drug","name":"Camizestrant","aka":[],"tldr":"Camizestrant is an oral oestrogen-receptor degrader approved in September 2026 for a new kind of decision: switching treatment when a blood test shows resistance developing, before the cancer visibly grows.","summary":"Camizestrant is AstraZeneca's next-generation oral SERD. SERENA-6 randomised patients whose ctDNA acquired an ESR1 mutation during first-line AI + CDK4/6 to switch to camizestrant + CDK4/6: PFS 16.0 vs 9.2 months (HR 0.44). After a 6-3 negative ODAC vote (April 2026) over the clinical meaning of acting on ctDNA, FDA granted accelerated approval on 4 September 2026, the first indication triggered by a molecular rather than radiographic event. SERENA-4 (first-line, unselected) and the adjuvant CAMBRIA trials will define its wider role.","status":"approved","asOf":"2026-09-07","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Camizestrant"}],"tags":[],"related":["oral-serd-plus-cdk46-after-esr1"],"cancers":["breast-hr-positive","hr-positive-metastatic-post-cdk46"],"sections":[],"technologies":["endocrine-therapy","liquid-biopsy"],"targets":["estrogen-receptor"],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":["esr1-mutation","oral-serd"],"trials":["serena-6","cambria","nct04644068","nct05774951","nct07427394","nct04711252","nct04214288","nct06380751","nct07647328"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Etcamah","code":"AZD9833","modality":"Oral SERD","mechanism":"Oral SERD: ER antagonist and degrader active against wild-type and ESR1-mutant receptors.","approvals":[{"region":"US","year":2026,"indication":"HR+/HER2- advanced breast cancer with an emergent ESR1 mutation on AI + CDK4/6, with a CDK4/6 inhibitor (accelerated, 4 Sep 2026)"},{"region":"EU","year":2026,"indication":"ER+/HER2- advanced breast cancer with emergent ESR1 mutation, with a CDK4/6 inhibitor; 20 Jul 2026"}],"mechanismSteps":["Serial ctDNA detects an ESR1 mutation while scans still show control","The mutant receptor no longer needs oestrogen, so the aromatase inhibitor stops working","Camizestrant binds and degrades both mutant and wild-type ER","CDK4/6 inhibition is continued","Progression is delayed by about seven months"],"dosing":{"route":"Oral","schedule":"75 mg once daily with a CDK4/6 inhibitor (per SERENA-6)","monitoring":"Bradycardia and visual effects (photopsia) reported with the class"},"toxicity":[{"event":"Photopsia (visual flashes)","anyGradePct":20,"note":"class effect, reversible"},{"event":"Bradycardia","anyGradePct":15},{"event":"Neutropenia (with CDK4/6)","grade3PlusPct":45,"note":"largely from the CDK4/6 partner"}],"access":[],"regulatoryEvents":[{"date":"2025-06-01","type":"filing","region":"US","note":"NDA based on SERENA-6"},{"date":"2026-04-30","type":"advisory-committee","region":"US","note":"ODAC voted 6-3 against (clinical relevance of ctDNA-triggered switch)","source":"https://www.cancernetwork.com/view/fda-odac-no-camizestrant-for-hr-her2-esr1-advanced-breast-cancer"},{"date":"2026-09-04","type":"accelerated-approval","region":"US","note":"Accelerated approval (Etcamah) The confirmatory requirement was still open 0.0 years later, when the FDA's table was read.","source":"https://www.fda.gov/news-events/press-announcements/fda-grants-accelerated-approval-new-breast-cancer-treatment","indication":"In combination with a CDK4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (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"}]},"route":"/drugs/camizestrant/","neighbours":{"pairing":[{"id":"oral-serd-plus-cdk46-after-esr1","kind":"pairing","name":"Oral SERD + CDK4/6 inhibitor after ESR1 emergence","route":"/pairings/oral-serd-plus-cdk46-after-esr1/"}],"cancer":[{"id":"hr-positive-early-high-risk","kind":"cancer","name":"High-risk early HR-positive breast cancer","route":"/cancers/hr-positive-early-high-risk/"},{"id":"breast-hr-positive","kind":"cancer","name":"HR-positive / HER2-negative breast cancer","route":"/cancers/breast-hr-positive/"},{"id":"hr-positive-metastatic-post-cdk46","kind":"cancer","name":"HR-positive metastatic breast cancer after CDK4/6 inhibitors","route":"/cancers/hr-positive-metastatic-post-cdk46/"}],"technology":[{"id":"endocrine-therapy","kind":"technology","name":"Endocrine therapy (SERMs, AIs, SERDs)","route":"/technologies/endocrine-therapy/"},{"id":"liquid-biopsy","kind":"technology","name":"Liquid biopsy (ctDNA)","route":"/technologies/liquid-biopsy/"},{"id":"oral-serds","kind":"technology","name":"Oral SERDs","route":"/technologies/oral-serds/"}],"target":[{"id":"estrogen-receptor","kind":"target","name":"Estrogen receptor (ERα)","route":"/targets/estrogen-receptor/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"term":[{"id":"esr1-mutation","kind":"term","name":"ESR1 mutation","route":"/terms/esr1-mutation/"},{"id":"oral-serd","kind":"term","name":"Oral SERD","route":"/terms/oral-serd/"}],"trial":[{"id":"nct04711252","kind":"trial","name":"A Comparative Study of AZD9833 Plus Palbociclib Versus Anastrozole Plus Palbociclib in Patients With ER-Positive HER2 Negative Breast Cancer Who Have Not Received Any Systemic Treatment for Advanced Disease","route":"/trials/nct04711252/"},{"id":"nct06188520","kind":"trial","name":"A First-in-human Dose Escalation and Expansion Study to Evaluate the Safety, and Tolerability of AZD8421 Alone or in Combination in Participants With ","route":"/trials/nct06188520/"},{"id":"nct07647328","kind":"trial","name":"A Phase IIIb Study to Evaluate Camizestrant Plus Ribociclib in ER-positive, HER2-negative Advanced Breast Cancer","route":"/trials/nct07647328/"},{"id":"nct05774951","kind":"trial","name":"A Study of Camizestrant in ER+/HER2- Early Breast Cancer After at Least 2 Years of Standard Adjuvant Endocrine Therapy","route":"/trials/nct05774951/"},{"id":"nct04214288","kind":"trial","name":"A Study to Investigate Efficacy and Safety With Oral AZD9833 Compared With Intramuscular Fulvestrant in Post-menopausal Women at Least 18 Years of Age With Advanced ER-positive HER2 Negative Breast Cancer","route":"/trials/nct04214288/"},{"id":"cambria","kind":"trial","name":"CAMBRIA-1 & CAMBRIA-2","route":"/trials/cambria/"},{"id":"nct06380751","kind":"trial","name":"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","route":"/trials/nct06380751/"},{"id":"serena-6","kind":"trial","name":"SERENA-6","route":"/trials/serena-6/"},{"id":"nct04644068","kind":"trial","name":"Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies","route":"/trials/nct04644068/"},{"id":"nct07427394","kind":"trial","name":"Study to Evaluate the Safety and Tolerability of Camizestrant in Combination With Atirmociclib in Women With Advanced Breast Cancer","route":"/trials/nct07427394/"}],"idea":[{"id":"idea-late-recurrence-interception","kind":"idea","name":"Intercepting late recurrence with ctDNA surveillance and oral SERDs","route":"/ideas/idea-late-recurrence-interception/"},{"id":"idea-ctdna-switch-generalised","kind":"idea","name":"Molecular-progression switching beyond ESR1","route":"/ideas/idea-ctdna-switch-generalised/"}],"person":[{"id":"nicholas-turner","kind":"person","name":"Nicholas Turner","route":"/people/nicholas-turner/"}],"bottleneck":[{"id":"b-resistance","kind":"bottleneck","name":"Acquired resistance to every therapy","route":"/bottlenecks/b-resistance/"}],"biomarker":[{"id":"esr1-mutation-ctdna","kind":"biomarker","name":"ESR1 mutation (ligand-binding domain, usually in ctDNA)","route":"/biomarkers/esr1-mutation-ctdna/"}],"roadmap":[{"id":"hormonal-therapy-roadmap","kind":"roadmap","name":"Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test","route":"/roadmaps/hormonal-therapy-roadmap/"}],"pathway":[{"id":"breast-cancer-signalling","kind":"pathway","name":"Breast cancer (KEGG map)","route":"/pathways/breast-cancer-signalling/"}]}}