Afinitor – A Two-Pronged Attack Against Tuberous Sclerosis Complex

Pages: 5 Published: May 10, 2012 Report Code: GDHC0075VPT

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GlobalData’s new alert, Afinitor: A Two-Pronged Attack Against Tuberous Sclerosis Complex,” takes a look at the implications of the FDA’s recent approval of the drug for the treatment of angiomyolipomas, benign kidney tumors that affect a majority of people with this rare disease. This is the second indication for Afinitor in this patient population; in October 2010, the drug was approved for the treatment of a rare type of brain tumor in tuberous sclerosis complex (TSC) patients called subependymal giant cell astrocytoma (SEGA). The approval of Afinitor in a second indication for TSC means that the product is now available to fulfill an important unmet treatment need in this patient population.

Scope

Introduction and detail on TSC and its consequences, including angiomyolipomas and SEGA

Description of EXIST-2, the pivotal Phase III trial that established the efficacy and safety of Afinitor in treating angiomyolipomas in TSC patients

Limitations of surgery and other current treatments for TSC patients with angiomyolipomas and SEGA

Reasons to Buy

Understand the therapeutic and market implications of the approval of Afinitor in its second indication in TSC

Understand the market potential of Afinitor in additional cancer indications in the non-TSC population specifically, advanced breast cancer in postmenopausal women

Table of Contents

1 Table of Contents

2 Introduction

3 Afinitor – A Two-Pronged Attack Against Tuberous Sclerosis Complex

3.1 Tuberous Sclerosis Complex

3.2 Unmet Treatment Need in TSC

3.3 Phase III Trial of Afinitor in TSC Patients with Angiomyolipomas

3.4 Conclusions

4 Appendix

4.1 Methodology

4.1.1 Coverage

4.1.2 Secondary Research

4.1.3 Primary Research

4.1.4 Expert Panel Validation

4.2 Contact Us

4.3 Disclaimer

List of Tables

N/A

List of Figures

N/A

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