Everolimus
An mTOR-blocking pill that doubled progression-free time with exemestane in 2012 and is now paired with the oral SERD giredestrant.
BOLERO-2: PFS 7.8 vs 3.2 months (everolimus + exemestane vs exemestane) after non-steroidal AI; no OS benefit. Stomatitis (mitigated by dexamethasone mouthwash, SWISH), pneumonitis, and hyperglycaemia. evERA (2025) revived it as the partner of giredestrant after CDK4/6 inhibitors.
1.Binds FKBP12; the complex inhibits mTORC1
- Route
- Oral
- Schedule
- 10 mg once daily
- Dose modifications
- 5 mg for stomatitis or pneumonitis
- Monitoring
- Glucose, lipids, pneumonitis symptoms; steroid mouthwash prophylaxis
- Medicare
- Part D (self-administered)
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026). Generic everolimus is available and inexpensive relative to Afinitor.
- Commercial insurance
- covered on label
Multi-source generic on low-cost tiers; usually no prior authorisation. Cash prices without insurance are modest. Plans require the generic.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
- Appraised for
- Advanced renal cell carcinoma after previous treatment
- Notes
- Also HR-positive breast cancer with exemestane (TA421, 2016) and neuroendocrine tumours (TA449, 2017, with sunitinib).
- NHS England
- Routinely funded for the appraised indication (or via managed access)
Sources: NICE TA432 · SMC advice: everolimus. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2012 | HR+/HER2- advanced breast cancer with exemestane after NSAI failure |
| US | 2011 | Progressive pancreatic NETs |
| US | 2016 | Progressive non-functional lung and GI NETs |
| US | 2009 | Advanced RCC after sunitinib or sorafenib |
| US | 2012 | HR+/HER2- breast cancer with exemestane |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Stomatitis | 59% | 8% |
| Pneumonitis | 16% | 3% |
| Hyperglycaemia | 14% | 5% |
| Stomatitis | 64% | 7% |
| Rash | 49% | — |
| Hyperglycaemia | 13% | 5% |
| Pneumonitis | 17% | 2% |
| Stomatitis | 44% | — |
| Rash | 29% | — |
| Fatigue | 31% | — |
| Pneumonitis | 14% | — |
| Hyperglycaemia | 12% | — |
RADIANT-3. 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:"Everolimus" OR ABSTRACT:"Everolimus" OR TITLE:"Afinitor" OR ABSTRACT:"Afinitor") 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 Everolimus, not a curated reading list.