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Afinitor (Everolimus) - Summary

 
 



AFINITOR SUMMARY

AFINITOR (everolimus), an inhibitor of mTOR, is an antineoplastic agent.

AFINITOR® is indicated for the treatment of patients with advanced renal cell carcinoma after failure of treatment with sunitinib or sorafenib.


See all Afinitor indications & dosage >>

NEWS HIGHLIGHTS

Media Articles Related to Afinitor (Everolimus)

Novartis drug Afinitor® is first treatment for advanced pancreatic NET to provide overall survival of more than 3.5 years in Phase III trial
Source: Clinical Trials / Drug Trials News From Medical News Today [2014.10.03]
Novartis have presented final results on overall survival (OS) from a Phase III trial of Afinitor® (everolimus) tablets plus best supportive care (BSC) compared to placebo plus BSC in patients...

FDA OKs New Kids' Dose of Cancer Drug
Source: MedPage Today Product Alert [2012.08.30]
WASHINGTON -- The FDA has approved a pediatric dosage of the cancer drug everolimus (Afinitor Disperz) for the treatment of a rare brain tumor.

Unsuspected mutations caused patient's dramatic response and resistance to cancer drug
Source: Breast Cancer News From Medical News Today [2014.10.10]
The DNA of a woman whose lethal thyroid cancer unexpectedly "melted away" for 18 months has revealed new mechanisms of cancer response and resistance to the drug everolimus, said researchers from...

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Published Studies Related to Afinitor (Everolimus)

Efficacy and safety of everolimus for subependymal giant cell astrocytomas associated with tuberous sclerosis complex (EXIST-1): a multicentre, randomised, placebo-controlled phase 3 trial. [2013]
subependymal giant cell astrocytomas associated with tuberous sclerosis complex... INTERPRETATION: These results support the use of everolimus for subependymal

Everolimus for advanced pancreatic neuroendocrine tumours: a subgroup analysis evaluating Japanese patients in the RADIANT-3 trial. [2012]
enrolled in the RADIANT-3 study... CONCLUSIONS: These results support the use of everolimus as a valuable treatment

Long-term response with everolimus for metastatic renal cell carcinoma refractory to sunitinib. [2011.12]
A 70-year-old man with metastatic renal cell carcinoma developed progressive liver metastases after 8 weeks of treatment with the multitargeted tyrosine kinase inhibitor (TKI) sunitinib... This case illustrates the potential for patients with metastatic renal cell carcinoma, a malignancy with historically poor prognosis, to derive long-term benefit from everolimus when used in a manner consistent with its approved indication (after TKI therapy with sunitinib or sorafenib).

Impact of Lesion Length and Vessel Size on Clinical Outcomes After Percutaneous Coronary Intervention With Everolimus- Versus Paclitaxel-Eluting Stents Pooled Analysis From the SPIRIT (Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System) and COMPARE (Second-generation everolimus-eluting and paclitaxel-eluting stents in real-life practice) Randomized Trials. [2011.11]
OBJECTIVES: The aim of this study was to investigate the impact of reference vessel diameter (RVD) and lesion length (LL) on the relative safety and efficacy of everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES). BACKGROUND: Lesion length and RVD are well-known predictors of adverse events after percutaneous coronary intervention... CONCLUSIONS: Patients with short lesions in large vessels have low rates of MACE at 2 years after treatment with either EES or PES. In higher-risk patients with long lesions and/or small vessels, EES results in significant improvements in both clinical safety and efficacy outcomes. (A Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions; NCT00180310; SPIRIT III: A Clinical Evaluation of the Investigational Device XIENCE V Everolimus Eluting Coronary Stent System [EECSS] in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00180479; SPIRIT IV Clinical Trial: Clinical Evaluation of the XIENCE V Everolimus Eluting Coronary Stent System in the Treatment of Subjects With de Novo Native Coronary Artery Lesions; NCT00307047; A Randomized Controlled Trial of Everolimus-eluting Stents and Paclitaxel-eluting Stents for Coronary Revascularization in Daily Practice: The COMPARE Trial; NCT01016041). Copyright (c) 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Biodegradable polymer versus permanent polymer drug-eluting stents and everolimus- versus sirolimus-eluting stents in patients with coronary artery disease: 3-year outcomes from a randomized clinical trial. [2011.09.20]
OBJECTIVES: The aim of this study was to compare the 3-year efficacy and safety of biodegradable polymer with permanent polymer stents and of everolimus-eluting stents (EES) with sirolimus-eluting stents (SES). BACKGROUND: Biodegradable polymer drug-eluting stents (DES) offer potential for enhanced late outcomes in comparison with permanent polymer stents. In addition, there is increasing interest in the comparison of EES (Xience, Abbott Vascular, Abbott Park, Illinois) versus SES (Cypher, Cordis Corporation, Miami Lakes, Florida)... CONCLUSIONS: Biodegradable polymer and permanent polymer DES are associated with similar clinical outcomes at 3 years. In addition, EES are comparable to SES in terms of overall clinical efficacy and safety. (Intracoronary Stenting and Angiographic Results: Test Efficacy of 3 Limus-Eluting STents [ISAR-TEST 4]: Prospective, Randomized Trial of 3-limus Agent-eluting Stents With Different Polymer Coatings; NCT00598676). Copyright (c) 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

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Clinical Trials Related to Afinitor (Everolimus)

Everolimus (RAD001) in Metastatic Transitional Cell Carcinoma of the Urothelium [Recruiting]
The purpose of this study is to learn what effects, good and/or bad, Everolimus has on advanced urothelial cancer.

The goal of this clinical research study is to learn if the study drug Everolimus can shrink or slow the growth of urothelial cancer. The safety of this drug will also be studied. The patients physical state, changes in the size of the tumor, and laboratory findings taken while on-study will help us decide if Everolimus is safe and effective.

RAD001 (Everolimus) + Docetaxel + Cisplatin as Induction Chemotherapy in Patients With Local-Regional Advanced Head and Neck Cancer [Recruiting]
The purpose of this study is to test the safety of RAD001 (everolimus) tablets at different dose levels, when added to docetaxel and cisplatin. We want to find out what effects, good and/or bad, that everolimus has when added to docetaxel and cisplatin as treatment for head and neck cancer.

Everolimus (RAD001) in Primary Therapy of Waldenstrom's Macroglobulinemia [Recruiting]
The purpose of this research study is to determine the safety of RAD001(Everolimus) and the highest dose of this drug that can be given to people safely. RAD001(Everolimus) is a drug that works by preventing cells in the body from growing and dividing. Information from basic and Phase I clinical research studies suggests that RAD001 also may help to prevent tumor growth in people with relapsed or refractory lymphoma.

Radiation Therapy (IMRT) + RAD001 (Everolimus) + Cisplatin for Patients With Head and Neck Cancer [Recruiting]
The purpose of this study is to determine the best doses of RAD001 (everolimus) tablets and cisplatin to give to patients who are receiving radiation therapy for head and neck cancer.

Everolimus (RAD001) for the Treatment of Malignant Pleural Mesothelioma With Merlin/NF2 Loss as a Biomarker to Predict Sensitivity [Recruiting]
For patients with malignant pleural mesothelioma that has grown despite treatment with standard chemotherapy, no treatment has yet proven beneficial. The purpose of this study is to find out what effects, both good and bad, that everolimus has on the cancer. Everolimus works by blocking a protein that helps the cancer grow. The goal of this clinical research study is to learn if the study drug everolimus can shrink or slow the growth of mesothelioma. The safety of this drug will also be studied. The patients' physical state, changes in the size of the tumor, and laboratory findings taken during the study will help us decide if everolimus is safe and effective.

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Reports of Suspected Afinitor (Everolimus) Side Effects

Neoplasm Malignant (362)Neoplasm Progression (337)Death (296)Fatigue (196)Dyspnoea (190)Pyrexia (173)Diarrhoea (150)Cough (123)Pneumonia (119)Anaemia (113)more >>


Page last updated: 2014-10-10

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