Drug updated on 9/4/2024
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.
Latest News
Summary
- Afinitor (everolimus) 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; 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; for the treatment of adults with advanced renal cell carcinoma (RCC) after failure of treatment with sunitinib or sorafenib; for the treatment of adults with renal angiomyolipoma and tuberous sclerosis complex (TSC), not requiring immediate surgery; 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; and for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures.
- This summary is based on the review of 10 systematic review(s)/meta-analysis(es). [1-10]
- Refractory Epilepsy in Tuberous Sclerosis (TS): Everolimus demonstrated a response rate ranging from 28.6% to 100% in controlling refractory epilepsy in pediatric patients with TS.
- Advanced or Metastatic Renal Cell Carcinoma (RCC): Everolimus showed a relatively favorable safety profile but was not the most effective treatment for progression-free survival (PFS). Combination with lenvatinib had worse safety outcomes compared to most other treatments, except lenvatinib alone.
- Cardiac Rhabdomyomas (CRs) in Tuberous Sclerosis Complex (TSC): Everolimus resulted in 90.9% clinical improvement and a 95.1% reduction in CR size in children with TSC.
- Neuroendocrine Tumors (NETs): Everolimus showed varying efficacy depending on combination; alone, it had a PFS hazard ratio (HR) of 0.36 for pancreatic NETs, and when combined with somatostatin analogues, the HR was 0.12 for gastrointestinal NETs.
- Refractory Epilepsy in Tuberous Sclerosis (TS): Adverse effects mostly led to dropouts; however, these effects were primarily of low severity. There is no direct comparison with other drugs.
- Advanced or Metastatic Renal Cell Carcinoma (RCC): Everolimus exhibited the lowest risk for grade ≥3 gastrointestinal and respiratory adverse events, but lenvatinib plus everolimus had a higher risk of renal toxicity.
- Pancreatic Neuroendocrine Tumors (pNETs): Everolimus was associated with higher discontinuation rates and a greater incidence of grade 3/4 hematological and nephrotoxicity compared to Lu-DOTATATE.
- There is no population types or subgroups information available in the reviewed studies.
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 |