Everolimus

(Afinitor®)

Everolimus

Drug updated on 4/17/2024

Dosage FormTablet (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 ClassKinase 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.

Latest News

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Summary
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  • 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 TitleYearSource
Afinitor (everolimus) Prescribing Information.2022Novartis Pharmaceuticals Corporation East Hanover, New Jersey

Systematic Reviews / Meta-Analyses

Document TitleYearSource
Everolimus as a therapeutic option in refractory epilepsy in children with tuberous sclerosis: A systematic review. 2023Arquivos de neuro-psiquiatria
Optimizing targeted drug selection in combination therapy for patients with advanced or metastatic renal cell carcinoma: A systematic review and network meta-analysis of safety. 2023Cancer Medicine
Treatment of cardiac rhabdomyomas with mTOR inhibitors in children with tuberous sclerosis complex-A systematic review.2021International Journal of Environmental Research and Public Health
Relationship between metabolic toxicity and efficacy of everolimus in patients with neuroendocrine tumors: A pooled analysis from the randomized, phase 3 RADIANT-3 and RADIANT-4 trials.2021Cancer
Treatment for gastrointestinal and pancreatic neuroendocrine tumours: A network meta-analysis. 2021The Cochrane Database of Systematic Reviews
Treatment of advanced gastro-entero-pancreatic neuro-endocrine tumors: A systematic review and network meta-analysis of phase III randomized controlled trials.2021Cancers
Endocrine therapies in postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative, pretreated, advanced breast cancer: A network meta-analysis.2020Medicine
The efficacy and safety of pharmacological treatments for lymphangioleiomyomatosis. 2020Respiratory research
177Lu-DOTATATE peptide receptor radionuclide therapy versus Everolimus in advanced pancreatic neuroendocrine tumors: A systematic review and meta-analysis.2019Nuclear Medicine Communications
Meta-analysis of randomized clinical trials comparing active treatment with placebo in metastatic neuroendocrine tumors.2019Oncologist

Clinical Practice Guidelines