Afinitor - A Two-Pronged Attack Against Tuberous Sclerosis Complex

GlobalData, May 2012, Pages: 5

Afinitor - A Two-Pronged Attack Against Tuberous Sclerosis Complex

Summary

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.

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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

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