1. No category

Oncology Development
Strategies - Considerable
commercial potential but
specific needs must be
addressed
Report Description
The oncology therapeutic area has seen significant development and advances over the last
decade. However, oncology has one of the lowest overall clinical success rates of all therapy
areas with only a third of oncology drugs that get to Phase III proceeding to approval. There
are a number of factors that will affect the likelihood of success in oncology drug
development and these must be taken into consideration when designing the clinical
development plan.
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Oncology clinical trials tend to be more complex than those in other therapy areas, largely
due to the number of endpoints that can be utilized, the growing need for adaptive trial
design and the types of patients that are eligible for the clinical studies. While overall survival
is the gold standard endpoint, achieving this is challenging for many oncology trials and other
endpoints such as progression-free survival are frequently used as surrogates.
Report Description
The approval of oncology drugs has been facilitated by regulatory mechanisms that have been
put in place to expedite the process for drugs with small patient populations or that address
areas of high unmet need. Programs to allow early access to developmental drugs are
becoming the norm in oncology, largely driven by the high unmet need and serious nature of
the disease, but also due to a desire to obtain real-life data.
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The report, “Oncology Development Strategies -Considerable commercial potential but specific
needs must be addressed”, was written to provide support and guidance to companies who are
both new entrants and long time players in the oncology space. CBR Pharma Insights provides
in-depth analysis on the challenges that exist in developing new oncology products and
launching them successfully into a challenging health care climate.
Report Description
Scope
• Oncology clinical trials details including endpoints, trial design, biomarkers, access to
patients, and regional data needs
• Regulatory strategies
• oncology launch strategies
Report Description
Key Reasons to Purchase
• Provides insight into why the development of oncology drugs is different compared to other
therapy areas and the implications for the overall process.
• Enables you to understand the regulatory mechanisms in place to expedite approval of new
oncology drugs and how these should be incorporated into strategic launch planning.
• Provides in-depth analysis of key aspects of oncology clinical trial design, examining the
merits of different endpoints, alternative trial designs and the importance of biomarkers in
oncology clinical trials and drug development.
• Better understand the key critical requirements when planning for a successful oncology
launch, including the impact of indication sequencing and how to address specific pricing
and reimbursement needs.
• Gain clear and actionable recommendations on crucial factors to consider when progressing
a new oncology drug through clinical testing, the regulatory process and launch.
Table Of Content
• Executive summary
• Methodology
• Why is oncology different?
• Oncology clinical trials
• Endpoints
• Trial design
• Biomarkers
• Access to patients
• Regional data needs
• Regulatory strategies
• Mechanisms in place that can facilitate oncology approvals
Table Of Content
• Critical success factors
• Effective oncology launch strategies
• Launch sequencing
• Pricing and reimbursement considerations
• Communication planning
• Launching with immature data
• Appendix
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