Camizestrant
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.
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.
1.Serial ctDNA detects an ESR1 mutation while scans still show control
- 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
- Notes
- Recently licensed; a NICE appraisal is scheduled or in progress. Interim access may be possible via the CDF interim funding route once NICE issues positive draft guidance.
Sources: NICE search: camizestrant. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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- 1 Jun 2025Filing / dealUS
NDA based on SERENA-6
- 30 Apr 2026Advisory committeeUS
ODAC voted 6-3 against (clinical relevance of ctDNA-triggered switch) source
- 4 Sept 2026ApprovalUS
Accelerated approval (Etcamah) source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2026 | HR+/HER2- advanced breast cancer with an emergent ESR1 mutation on AI + CDK4/6, with a CDK4/6 inhibitor (accelerated, 4 Sep 2026) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Photopsia (visual flashes) class effect, reversible | 20% | — |
| Bradycardia | 15% | — |
| Neutropenia (with CDK4/6) largely from the CDK4/6 partner | — | 45% |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Camizestrant" OR ABSTRACT:"Camizestrant" OR TITLE:"Etcamah" OR ABSTRACT:"Etcamah" OR TITLE:"AZD9833" OR ABSTRACT:"AZD9833") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Camizestrant, not a curated reading list.