Look Towards A New Future

Jul 26, 2012

Case Study: Personalized Cancer Therapy - Anticipated competition threatens to dampen commercial potential of new approvals

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
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
Buy your copy of this reports @

Report Details:
Published: July 2012
No. of Pages: 71

Price: Single User License- US $1900                Corporate User License- US $ 4750
                                  Request Sample

Table Of contents



Strategic scoping and focus
Datamonitor key findings
Related reports

Oncology overview
A move toward personalized therapy with the development of targeted drugs

Oncology biomarkers
Classification of cancer biomarkers
Targeted therapies and predictive biomarkers

Case study
Iressa (gefitinib; AstraZeneca)
Development approach
When to develop companion diagnostics
Internal or external companion diagnostic development

Patient population
(Untitled sub-section)
Herceptin (trastuzumab; Roche/Genentech/Chugai)
Erbitux (cetuximab; Bristol-Myers Squibb/Eli Lilly/Merck KGaA) and Vectibix (panitumumab; Amgen)
Companion diagnostics make cancer treatments more cost-effective
Reimbursement policies must consider personalized cancer therapy


Regulators and personalized cancer therapy
Regulations are changing to encourage companion diagnostic co-development
US regulatory authorities
EU regulatory authorities
Japanese regulatory authorities

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

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

Datamonitor reports

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 for further details.