Fulvestrant
Fulvestrant is a monthly injection that destroys the oestrogen receptor; it is the standard partner for many targeted drugs after hormone therapy stops working.
First selective oestrogen receptor degrader (2002). Backbone of PALOMA-3, MONARCH 2, MONALEESA-3, SOLAR-1, CAPItello-291, INAVO120, and the control arm of every oral SERD trial. Limitations: intramuscular 500 mg injections, slow steady state, and incomplete ER degradation, which motivated oral SERDs and the PROTAC vepdegestrant.
- Route
- Intramuscular
- Schedule
- 500 mg on days 1, 15, 29, then monthly
- Monitoring
- Injection-site reactions
- Medicare
- Part B (clinician-administered)
Given by infusion or injection in a clinic or hospital outpatient department, so it is a Part B drug: Medicare pays 80% after the Part B deductible and the patient owes 20% coinsurance, uncapped in Original Medicare unless a Medigap policy applies. Intramuscular injection in the clinic (HCPCS J9395); generic fulvestrant since 2019.
- Commercial insurance
- covered on label
Multi-source generic; covered under the medical benefit without prior authorisation in most plans, as part of standard regimens.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B). Not medical or financial advice; verify with your plan.
- Appraised for
- Locally advanced or metastatic breast cancer as monotherapy
- Notes
- Now generic and widely used on the NHS as the partner drug in CDK4/6, alpelisib and capivasertib combinations, all of which are NICE recommended.
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA239. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2002 | HR+ advanced breast cancer after antioestrogen therapy |
| US | 2017 | First-line HR+ advanced breast cancer (FALCON) |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Injection-site pain | 14% | — |
| Hot flushes | 13% | — |
| Arthralgia | 17% | — |
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:"Fulvestrant" OR ABSTRACT:"Fulvestrant" OR TITLE:"Faslodex" OR ABSTRACT:"Faslodex") 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 Fulvestrant, not a curated reading list.