Abstract
The Repurposing Drugs in Oncology (ReDO) Project seeks to repurpose well-known and well-characterised non-cancer drugs for new uses in oncology. The rationale for this project is presented, examining current issues in oncological drug development, challenges for health systems, and existing and future patient needs. In addition to discussing the advantages of repurposing, the paper also outlines some of the characteristics used in the selection of drug candidates by this project. Challenges in moving candidate drugs into clinical trial and subsequent practice are also discussed.
Highlights
The crisis is acute in oncology, where the success rate for new drugs from Phase I trial to US Food and Drug Administration (FDA) approval in the period 2003 to 2011 was around 6.7%, a figure that is about half the rate for non-oncological drugs [5]
The mean development time for antineoplastic drugs, from the time of the first filing of investigational new drug application to the granting of NDA/BLA approval, is estimated to be 8.3 years [6]. This apparent slowdown of new oncology drugs emerging from product pipelines into clinical use is occurring against a twin backdrop, one of increased cancer incidence across the globe, and the other of existing significant therapeutic challenge in many types of malignant disease
This paper has outlined a number of issues with current oncological drug development, economic pressures imposed on health systems due to increased costs of new cancer treatments, and the increasing incidence of cancer, both in developed and developing countries
Summary
To achieve this future state will require a wide range of targeted drugs with low toxicity, and at a cost that makes such combinations feasible, we will need to be able to identify specific groups of patients that will benefit from these combinations and be able to carry out the necessary clinical trials to prove the efficacy of the treatment protocols Such combinations may involve drugs developed by different companies, with the concomitant logistical and business issues involved in bringing these products together in a single trial. Can be seen as a response to the declining productivity of oncological drug development, as a strategy to reduce development times, and as a source of low-cost treatments to meet the increased demands and unmet needs of cancer patients It is, in a sense, a very different strategy to the dominant paradigm that guides the development of targeted therapies, but one which may represent a relatively untapped source of novel therapies
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