The Problem We’re Solving
New uses for generic drugs often lack a clear path into care.
Across multiple cancers, more than 100 generic drugs developed for other diseases have promising clinical data indicating that they could be repurposed for treating cancer. Yet these treatments rarely become part of the standard of care.
The reason is structural: the current drug development system is optimized to move patent-protected products forward, not low-cost generics. There is no coordinated pathway for evaluating, validating, or advancing new cancer uses for off-patent drugs, even when high-quality evidence exists.
Much of this evidence has been generated through investigator-initiated research in academic centers, funded by government agencies or philanthropic organizations, or in industry-sponsored studies conducted before patents expired. These efforts can produce strong early and mid-stage clinical data, but typically stop short of the large, coordinated trials and regulatory work needed to change guidelines or standard practice.
This system has driven the average cost of a new cancer drug to more than $150,000 per year. In the US, nearly half of people with cancer experience financial toxicity, meaning significant financial burden or distress related to their care. And globally, where access to new cancer drugs is often limited, affordable, evidence-supported options are even more essential.
The barrier is not the science. It’s that there is no mechanism to carry generic drugs through the a steps required for clinical consideration and guideline evaluation.
Why the System Fails
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Loss of Market Exclusivity
Once a drug becomes generic, any manufacturer can produce and sell it. Even if a company invested in research for a new use, pharmacy substitution means all manufacturers could sell the drug. While new-use patents exist, they don’t prevent competitors from selling the drug for off-label use.
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No ability to recover investment
Without exclusivity, no company can recover the cost of funding new trials or regulatory submissions, so promising new uses for existing drugs are not pursued.
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Regulatory and guideline barriers
Inclusion in national guidelines and FDA labeling updates requires comprehensive evidence packages, which are usually produced by industry for new drugs. Only the manufacturer holding the original New Drug Application (NDA) can request changes to a drug’s labeling, such as the addition of new uses. When a drug is generic its manufacturers have no financial incentive to do this, so labeling, clinician confidence, and coverage do not advance.
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Fragmented evidence trapped in the literature
Hundreds of thousands of studies exist across journals and cancer types, but they are scattered, inconsistent in quality, and rarely synthesized. Without a clear, trusted summary of the totality of evidence, clinicians lack the guidance needed to translate these findings into practice.
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No organizational owner for the process
When a drug goes off-patent, no company, agency, or institution is responsible for assembling the evidence, pursuing regulatory updates, or supporting clinical awareness. Repurposing opportunities remain orphaned.
The Cost of Inaction
Promising therapies never advance beyond early studies, leaving potential survival and quality of life benefits unrealized.
Clinicians lack clear, trustworthy guidance on when and how to use these options.
Patients miss affordable, evidence-supported treatments that could improve outcomes or quality of life.
Health systems, payers, and families lose opportunities to lower healthcare costs, contributing to higher drug spending.
This is a solvable problem, though not a simple one.
Reboot Rx was created to address this structural gap, by accelerating access to the evidence-supported opportunities already within reach.