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
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
Report Details:
Published: July 2012
No. of Pages: 71
Price: Single User License- US $1900 Corporate User License- US $ 4750
Table Of contents
OVERVIEW
Catalyst
Summary
EXECUTIVE SUMMARY
Strategic scoping and focus
Datamonitor key findings
Related reports
INTRODUCTION
Oncology overview
A move toward personalized therapy with the development of targeted drugs
BIOMARKERS
Oncology biomarkers
Definition
Classification of cancer biomarkers
Targeted therapies and predictive biomarkers
DRUG AND COMPANION DIAGNOSTIC DEVELOPMENT
Case study
Iressa (gefitinib; AstraZeneca)
Development approach
Overview
When to develop companion diagnostics
Internal or external companion diagnostic development
COMMERCIAL POTENTIAL
Patient population
(Untitled sub-section)
Herceptin (trastuzumab; Roche/Genentech/Chugai)
Erbitux (cetuximab; Bristol-Myers Squibb/Eli Lilly/Merck KGaA) and Vectibix (panitumumab; Amgen)
Cost-effectiveness
Companion diagnostics make cancer treatments more cost-effective
Reimbursement
Reimbursement policies must consider personalized cancer therapy
REGULATORS
Regulators and personalized cancer therapy
Regulations are changing to encourage companion diagnostic co-development
US regulatory authorities
EU regulatory authorities
Japanese regulatory authorities
KEY MARKETED PERSONALIZED CANCER THERAPIES
Zelboraf (vemurafenib; Roche/Daiichi Sankyo)
Personalized therapy profile
Drug overview
Companion diagnostic overview
Development path
Commercial potential
Clinical and commercial assessment
Xalkori (crizotinib; Pfizer)
Drug profile
Drug overview
Companion diagnostic overview
Development path
Commercial potential
Clinical and commercial potential
KEY PIPELINE PERSONALIZED CANCER TERAPIES
Dabrafenib (GSK-2118436; GlaxoSmithKline)
Personalized therapy profile
Drug overview
Companion diagnostic overview
Market potential
Trametinib (GSK-1120212; GlaxoSmithKline)
Personalized therapy profile
Drug overview
Companion diagnostic overview
Market potential
Tomtovok (afatinib; Boehringer Ingelheim)
Personalized therapy profile
Drug overview
Companion diagnostic overview
Market potential
Other pipeline personalized cancer therapies
Overview of other pipeline personalized cancer therapies
BIBLIOGRAPHY
Journals
Websites
Datamonitor reports
Other
APPENDIX
Forecast methodology
Volume and value forecast methodology
Price assumptions
Contributing experts
Report methodology
List Of Tables
Table: Biomarker classification according to modality
Table: Examples of available companion diagnostics for targeted cancer therapies, 2012
Table: Approved cancer drugs with biomarkers on label, 2012
Table: Iressa: key historical events, 1994–2010
Table: Pharmaceutical company acquisitions of diagnostic companies, 2012
Table: Examples of diagnostic and pharmaceutical company partnerships for cancer therapies, 2010–12
Table: FDA-approved HER2 diagnostic tests, 2012
Table: FDA- and EMA-approved drugs with mandatory biomarker tests, 2012
Table: Zelboraf – drug profile, 2012
Table: Zelboraf sales forecast, by country ($m), 2011–21
Table: Xalkori – drug profile, 2012
Table: Xalkori sales forecast, by country ($m), 2011–21
Table: Dabrafenib – drug profile, 2012
Table: Trametinib – drug profile, 2012
Table: Tomtovok – drug profile, 2012
Table: Key pipeline personalized cancer therapies
Contact sales@reportsandreports.com for further details.
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
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
Report Details:
Published: July 2012
No. of Pages: 71
Price: Single User License- US $1900 Corporate User License- US $ 4750
Table Of contents
OVERVIEW
Catalyst
Summary
EXECUTIVE SUMMARY
Strategic scoping and focus
Datamonitor key findings
Related reports
INTRODUCTION
Oncology overview
A move toward personalized therapy with the development of targeted drugs
BIOMARKERS
Oncology biomarkers
Definition
Classification of cancer biomarkers
Targeted therapies and predictive biomarkers
DRUG AND COMPANION DIAGNOSTIC DEVELOPMENT
Case study
Iressa (gefitinib; AstraZeneca)
Development approach
Overview
When to develop companion diagnostics
Internal or external companion diagnostic development
COMMERCIAL POTENTIAL
Patient population
(Untitled sub-section)
Herceptin (trastuzumab; Roche/Genentech/Chugai)
Erbitux (cetuximab; Bristol-Myers Squibb/Eli Lilly/Merck KGaA) and Vectibix (panitumumab; Amgen)
Cost-effectiveness
Companion diagnostics make cancer treatments more cost-effective
Reimbursement
Reimbursement policies must consider personalized cancer therapy
REGULATORS
Regulators and personalized cancer therapy
Regulations are changing to encourage companion diagnostic co-development
US regulatory authorities
EU regulatory authorities
Japanese regulatory authorities
KEY MARKETED PERSONALIZED CANCER THERAPIES
Zelboraf (vemurafenib; Roche/Daiichi Sankyo)
Personalized therapy profile
Drug overview
Companion diagnostic overview
Development path
Commercial potential
Clinical and commercial assessment
Xalkori (crizotinib; Pfizer)
Drug profile
Drug overview
Companion diagnostic overview
Development path
Commercial potential
Clinical and commercial potential
KEY PIPELINE PERSONALIZED CANCER TERAPIES
Dabrafenib (GSK-2118436; GlaxoSmithKline)
Personalized therapy profile
Drug overview
Companion diagnostic overview
Market potential
Trametinib (GSK-1120212; GlaxoSmithKline)
Personalized therapy profile
Drug overview
Companion diagnostic overview
Market potential
Tomtovok (afatinib; Boehringer Ingelheim)
Personalized therapy profile
Drug overview
Companion diagnostic overview
Market potential
Other pipeline personalized cancer therapies
Overview of other pipeline personalized cancer therapies
BIBLIOGRAPHY
Journals
Websites
Datamonitor reports
Other
APPENDIX
Forecast methodology
Volume and value forecast methodology
Price assumptions
Contributing experts
Report methodology
List Of Tables
Table: Biomarker classification according to modality
Table: Examples of available companion diagnostics for targeted cancer therapies, 2012
Table: Approved cancer drugs with biomarkers on label, 2012
Table: Iressa: key historical events, 1994–2010
Table: Pharmaceutical company acquisitions of diagnostic companies, 2012
Table: Examples of diagnostic and pharmaceutical company partnerships for cancer therapies, 2010–12
Table: FDA-approved HER2 diagnostic tests, 2012
Table: FDA- and EMA-approved drugs with mandatory biomarker tests, 2012
Table: Zelboraf – drug profile, 2012
Table: Zelboraf sales forecast, by country ($m), 2011–21
Table: Xalkori – drug profile, 2012
Table: Xalkori sales forecast, by country ($m), 2011–21
Table: Dabrafenib – drug profile, 2012
Table: Trametinib – drug profile, 2012
Table: Tomtovok – drug profile, 2012
Table: Key pipeline personalized cancer therapies
Contact sales@reportsandreports.com for further details.
