Abstract
The repositioning or “repurposing” of existing therapies for alternative disease indications is an attractive approach that can save significant investments of time and money during drug development. For cancer indications, the primary goal of repurposed therapies is on efficacy, with less restriction on safety due to the immediate need to treat this patient population. This report provides a high-level overview of how drug developers pursuing repurposed assets have previously navigated funding efforts, regulatory affairs, and intellectual property laws to commercialize these “new” medicines in oncology. This article provides insight into funding programs (e.g., government grants and philanthropic organizations) that academic and corporate initiatives can leverage to repurpose drugs for cancer. In addition, we highlight previous examples where secondary uses of existing, Food and Drug Administration- or European Medicines Agency-approved therapies have been predicted in silico and successfully validated in vitro and/or in vivo (i.e., animal models and human clinical trials) for certain oncology indications. Finally, we describe the strategies that the pharmaceutical industry has previously employed to navigate regulatory considerations and successfully commercialize their drug products. These factors must be carefully considered when repurposing existing drugs for cancer to best benefit patients and drug developers alike.
Highlights
Drug repurposing is gaining popularity as an approach to develop new medicines
The safety, efficacy, and toxicity of an existing drug have been extensively studied, and robust data have already been collected toward gaining approval by the United States (US) Food and Drug Administration (FDA) and/or the European Medicines Agency (EMA) for a specific indication
Cancer is a multistage illness with intervention possible during initiation, rapid heterogenous growth, metastasis, and/or recurrence. These features suggest that cancer-focused drug repurposing would be mutually beneficial for patients and pharmaceutical companies alike, with the following sections providing an overview of current opportunities and potential challenges when venturing into this field
Summary
Drug repurposing is gaining popularity as an approach to develop new medicines. this strategy of using existing therapeutics for new indications has demonstrated success through previous observational studies and serendipity, such as sildenafil (Viagra), a phosphodiesterase inhibitor initially developed to treat angina and repurposed as a medication for erectile dysfunction, as well as metformin (Glucophage), a common diabetes medication that is the active chemical in 100+ ongoing Phase II and Phase III clinical trials as a cancer therapeutic [1]. Ideal candidates for drug repurposing are entities that have undergone clinical trials and have been unsuccessful for reasons other than safety (i.e., failed efficacy milestones). Since these drugs have already been deemed. Cancer is a multistage illness with intervention possible during initiation, rapid heterogenous growth, metastasis, and/or recurrence. These features suggest that cancer-focused drug repurposing would be mutually beneficial for patients and pharmaceutical companies alike, with the following sections providing an overview of current opportunities and potential challenges when venturing into this field
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