Drug updated on 4/17/2024
| Dosage Form | Tablet (oral; afinitor: 2.5 mg, 5 mg, 7.5 mg, and 10 mg); Tablet (oral suspension; afinitor disperz: 2 mg, 3 mg, and 5 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Afinitor is indicated for the treatment of postmenopausal women with advanced hormone receptor-positive, HER2- negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole.
- Afinitor is indicated for the treatment of adults with progressive neuroendocrine tumors of pancreatic origin (PNET) and adults with progressive, well-differentiated, non-functional neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin that are unresectable, locally advanced or metastatic.
- Afinitor is indicated for the treatment of adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib.
- Afinitor is indicated for the treatment of adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery.
- Afinitor and Afinitor Disperz are indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.
- Afinitor Disperz is indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC associated partial-onset seizures.
Summary
- Everolimus (Afinitor) is indicated for various conditions including advanced hormone receptor-positive, HER2-negative breast cancer in postmenopausal women, progressive neuroendocrine tumors of pancreatic origin, and gastrointestinal or lung origin in adults, advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib in adults, renal angiomyolipoma and tuberous sclerosis complex not requiring immediate surgery in adults. It is also used to treat adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma that requires therapeutic intervention but cannot be curatively resected.
- The information was derived from nine systematic reviews/meta-analyses on Everolimus.
- In the treatment of refractory epilepsy associated with Tuberous Sclerosis Complex (TSC) in children, everolimus has shown beneficial effects despite low-severity adverse effects. This indicates a significant advantage for this population compared to other treatments.
- For patients suffering from Advanced/Metastatic Renal Cell Carcinoma (RCC), everolimus presents a better safety profile regarding grade ≥3 adverse events as well as gastrointestinal and respiratory ones when compared to other targeted therapies such as VEGF-TKIs and mTOR inhibitors.
- When treating Cardiac Rhabdomyomas among children diagnosed with TSC, everolimus can serve as a temporary yet safe solution especially for high-risk or non-operable tumors. Clinical improvement along with tumor size reduction was reported at an impressive rate of 90.9%.
- Among patients dealing with Neuroendocrine Tumors experiencing hyperglycemia & hypercholesterolemia side effects, the effectiveness of Everolimus remains steady without any significant impact on therapy outcomes, which makes it more appealing than its counterparts under these circumstances.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Afinitor (everolimus) Prescribing Information. | 2022 | Novartis Pharmaceuticals Corporation East Hanover, New Jersey |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| EANO - EURACAN - SNO Guidelines on circumscribed astrocytic gliomas, glioneuronal, and neuronal tumors. | 2022 | Neuro-oncology |
| JNETS clinical practice guidelines for gastroenteropancreatic neuroendocrine neoplasms: Diagnosis, treatment, and follow-up: A synopsis. | 2021 | Journal of Gastroenterology |
| SEOM clinical guideline for treatment of kidney cancer (2019). | 2020 | Clinical and Translational Oncology |