Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: AstraZeneca AB, SE-151 85 Södertälje, Sweden
Etcamah in combination with a CDK4/6 inhibitor (palbociclib, ribociclib, or abemaciclib) is indicated for the treatment of adult patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1-mutation and without disease progression during first-line endocrine therapy in combination with a CDK4/6 inhibitor (for biomarker based patient-selection, see section 4.2 and 5.1).
In pre- or peri-menopausal women and in men, Etcamah plus a CDK4/6 inhibitor should be combined with a luteinizing hormone releasing hormone (LHRH) agonist or antagonist.
Treatment should be initiated and supervised by a physician experienced in the use of anticancer medicinal products.
Patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer on first-line endocrine treatment should be selected for treatment based on the presence of ESR1-mutations in plasma or tumour specimen collected every 3 months until an ESR1-mutation has been detected, and which should be assessed by a CE-marked in vitro diagnostic (IVD) medical device with the corresponding intended purpose (see section 5.1). If a CE-marked IVD is not available, an alternative validated test should be used.
The recommended dose of Etcamah in combination with a CDK4/6 inhibitor is 75 mg once daily. The CDK4/6 inhibitor should be continued at the same dose at the time of initiation with Etcamah as when the ESR1m was detected.
Please also refer to the summary of product characteristics (SmPC) of the CDK4/6 inhibitor or LHRH agonist or antagonist for the recommended dosing information. If the CDK4/6 inhibitor is permanently discontinued, Etcamah should also be discontinued.
Treatment with Etcamah should continue as long as clinical benefit is observed or until unacceptable toxicity occurs.
If a dose of Etcamah is missed, it can be taken immediately within 6 hours after the time it is usually taken. After more than 6 hours, the dose should be skipped for that day. The next dose of Etcamah should be taken at the usual time.
If the patient vomits, an additional dose should not be taken. The next dose of Etcamah should be taken at the usual time.
For the combination of Etcamah with a CDK4/6 inhibitor, ECG should be assessed before initiating treatment, at approximately day 8 and day 15 of the first cycle, and then as clinically indicated. Thereafter, monitoring during combination treatment should be performed according to the recommendations in the SmPC of the co-administered CDK4/6 inhibitor. In case of QTc prolongation during treatment, more frequent ECG monitoring is recommended.
In addition, for the combination of Etcamah with ribociclib, treatment should be initiated only in patients with QTcF values less than 450 msec, and analysis of electrolytes should be performed before initiating combination treatment, at day 15 and as clinically indicated. Refer to the ribociclib SmPC for dose modification guidelines and other relevant safety information.
Treatment with Etcamah may be temporarily interrupted and/or discontinued to manage adverse reactions per dose modification guideline provided in Table 1.
Table 1. Recommended dose modification for Etcamah:
| NCI CTCAE (v5.0) Toxicity | Action |
| Bradycardiaa Symptomatic, CTCAE Grade ≥ 2 | Consider holding Etcamah dosing whilst evaluating concomitant medicinal products known to cause bradycardia. If no contributing concomitant medicinal product is identified, withhold Etcamah until bradycardia symptoms resolve. If a contributing concomitant medicinal product is identified, consider discontinuing or modifying the dose of this agent until bradycardia symptoms resolve and then restart Etcamah dosing. Consider reassessing the heart rate after restart of Etcamah dosing at next clinical visit or as clinically indicated. Permanently discontinue Etcamah for persistent symptomatic bradycardia. |
| Visual effectsb CTCAE Grade ≥ 2/limiting instrumental ADLs | Consider referring to an eye care professional, if visual symptoms are progressive, persistent, or interfere with instrumental ADLs. Decision regarding treatment interruption should be based on clinical assessment. |
| Grade 3 or higher adverse event assessed as causally related to Etcamah | Hold Etcamah dosing until resolution to CTCAE Grade 2 or below, then restart Etcamah dosing. Consider permanently discontinuing Etcamah for recurrent Grade 3 or higher AEs. |
ADL = Activities of daily living; AE = Adverse Event; CTCAE = Common Terminology Criteria for Adverse Events; NCI = National Cancer Institute.
a Bradycardia includes bradycardia and sinus bradycardia.
b Visual effects include photopsia, vision blurred, visual impairment, diplopia, and photophobia of eye disorders MedDRA SOC, and visual perseveration of nervous system disorders MedDRA SOC.
No clinically relevant pharmacokinetic interaction was observed when camizestrant was co-administered with abemaciclib or palbociclib. When camizestrant 75 mg was administered in combination with ribociclib, camizestrant exposure increased to levels comparable to those observed with a 150 mg monotherapy dose (see section 4.9).
No dose adjustment of camizestrant is required for elderly patients (see section 5.2).
No dose adjustment of camizestrant is required for patients with mild or moderate renal impairment. Etcamah is not recommended for patients with severe renal impairment (see section 5.2).
No dose adjustment of camizestrant is required for patients with mild (NCI criteria) hepatic impairment. As a precautionary measure, the use of camizestrant in patients with moderate and severe hepatic impairment should be avoided. Patients with mild hepatic impairment are allowed to take camizestrant (see sections 4.4 and 5.2).
The safety and efficacy of camizestrant in children aged 0-18 years has not been established. No data are available.
Oral use.
The tablet should be swallowed whole with water and may be taken with or without food, at approximately the same time each day. Etcamah should not be ingested if it is broken, cracked, or otherwise not intact. The tablet should not be chewed, crushed, dissolved, or divided because these methods have not been studied in clinical studies.
There is no specific treatment in the event of Etcamah overdose. No Maximum Tolerated Dose (MTD) was reached in the phase I studies in which patients received a daily monotherapy dose up to 450 mg. The safety profile of patients treated with once daily doses of 150 mg Etcamah was consistent with the established safety profile of Etcamah at the recommended 75 mg once daily dose (see section 4.8). In case of suspected overdose, patients should be closely monitored and treated symptomatically, if necessary.
3 years.
This medicinal product does not require any special storage conditions.
28x1 film-coated tablets in aluminium/aluminium perforated unit dose blisters. 2 blisters with 14 film-coated tablets each.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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