Drug updated on 11/1/2024
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
- This summary is based on the review of 19 systematic review(s)/meta-analysis(es). [1-19]
- Renal Cell Carcinoma (RCC): Lenvatinib combined with Everolimus ranked highest in effectiveness, showing superior overall survival (OS) (HR (hazard ratio) = 0.44; 95% CI (confidence interval) = 0.24-0.82), progression-free survival (PFS) (HR = 0.13; 95% CI = 0.07-0.24), and objective response rate (ORR) (OR (odds ratio) = 35.95; 95% CI = 11.55-111.87) compared to placebo. Cabozantinib ranked second in OS (HR = 0.57) and PFS (HR = 0.19), while Nivolumab had the lowest risk of severe adverse events (SAE).
- Tuberous Sclerosis Complex (TSC): Oral Everolimus demonstrated significant effectiveness in reducing renal angiomyolipoma size by 50% (RR = 24.69; P = 0.001), reducing SEGA tumor size by 50% (RR = 27.85; P = 0.02), and decreasing seizure frequency by 25% and 50% (P = 0.0001 and P = 0.0004, respectively). It also showed notable improvement in skin responses (RR = 5.78; P = 0.0002).
- Neuroendocrine Tumors (NETs): Everolimus and Sirolimus effectively stabilized lung function and reduced angiomyolipomas in patients with LAM, with Everolimus also enhancing progression-free survival (PFS) and OS in patients with metastatic NETs, highlighting its clinical benefit in these conditions.
- Renal Cell Carcinoma (RCC): The combination of Everolimus with Lenvatinib was associated with a higher risk of severe adverse events (SAEs) compared to other treatments, necessitating frequent dose adjustments, interruptions, or withdrawals due to adverse effects. Nivolumab presented the lowest incidence of SAEs among the RCC treatments.
- Tuberous Sclerosis Complex (TSC): While overall adverse events were similar between Everolimus and placebo, patients on Everolimus experienced more severe adverse events, leading to increased treatment modifications.
- Neuroendocrine Tumors (NETs): Everolimus and Sirolimus were generally well-tolerated with primarily mild side effects, although Everolimus showed a higher rate of severe adverse events compared to placebo.
- Population studies included previously treated adolescents and adults with metastatic renal cell carcinoma (RCC), neuroendocrine tumors (NETs), and tuberous sclerosis complex (TSC), with age ranges spanning from 3 months to 65 years for TSC. Subgroup analyses identified no significant differences in adverse events between children and adults with TSC and showed that RCC patients with higher mTOR inhibitor levels had increased discontinuation rates due to adverse effects.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Afinitor (everolimus) Prescribing Information. | 2022 | Novartis Pharmaceuticals Corporation, East Hanover, NJ |
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 |