Introduction

The treatment of cancer has seen a dramatic shift with the addition of molecular targeted therapies. The mixed and unpredictable responses to these targeted therapies are driving the pharmaceutical industry to search for disease and patient characteristics which confer the best response rates. Identification of biomarkers and companion diagnostics will pave the way for personalized cancer therapy.

Features and benefits

• In-depth analysis of companion diagnostic development – when to start development, internal or partnership development, with case study examples
• In-depth analysis of personalized cancer therapy commercial potential – with patient population analysis and case studies
• In-depth analysis of US, EU, and Japanese current and developing regulatory processes for personalized cancer therapy
• Extensive analysis of Zelboraf and Xalkori, including seven major market sales forecasts 2011-21 and detailed development timelines

Highlights

Pharmaceutical companies face a number of important decisions regarding personalized therapy development. Selecting the correct time to begin companion diagnostic development will help improve the chances of approval and drive new drug uptake. Developers must also assess their position in the market before choosing internal or external development.

The development of BRAF inhibitor resistance and anticipated launch of GlaxoSmithKline’s two personalized therapies will undoubtedly impact Zelboraf’s commercial potential. The question remains as to whether a small subgroup of patients in one indication can commercially support two almost identical drugs.

Regulators have now realized that the regulatory framework must be altered to incorporate both drugs and companion diagnostics. The US, EU and Japanese authorities are all starting to change their guidelines to encourage personalized therapy development. However, there are still hurdles to overcome before co-development becomes common practice.

Your key questions answered

• Gain extensive insight into the clinical and commercial aspects of Zelboraf and Xalkori, including 2011-21 forecasts
• Identify key decisions when developing a drug and companion diagnostic, including internal or external development and when to start development
• Assess the changes in regulatory processes in the seven major markets as the paradigm of personalized cancer medicine grows