ArticleFrontiers in pharmacology2019
On-Label or Off-Label? Overcoming Regulatory and Financial Barriers to Bring Repurposed Medicines to Cancer Patients.
Article in Frontiers in pharmacology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 37 papers.
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Who cites it
37 citing papers in PubMed.
- Policy barriers to drug repurposing in Europe: different stakeholder perspectives identified during survey-based shortlisting of key challenges.Health policy OPEN · 2026Article
- Article
- Medicine Development and Access for Rare Diseases: Can We Do Better?Journal of inherited metabolic disease · 2026Review
- Impact of drug repurposing between 1985 and 2024 on pharmaceutical innovation.Communications medicine · 2026Article
- Disrupting Cancer Pathways with Nanogel-Encapsulated Wheatgrass Phytopharmaceuticals for Skin Cancer Therapy.Anti-cancer agents in medicinal chemistry · 2026Review
- Unbiased combination screening on repurposed drugs reveals synergistic potential of copanlisib and cerivastatin against chemoresistant high-grade serous ovarian cancer.Journal of ovarian research · 2025Article
- Overcoming barriers to off-patent drug repurposing: a lifecycle-based policy solutions.Frontiers in pharmacology · 2025Article
- Mapping the therapeutic versatility of WHO essential medicines: a systematic analysis of off-label indications.Therapeutic advances in drug safety · 2025Article
- New or repurposed: a novel classification system for the horizon scanning of innovative medicines.International journal of technology assessment in health care · 2024Article
- Clinical research framework proposal for ketogenic metabolic therapy in glioblastoma.BMC medicine · 2024Review
- Repurposing metabolic regulators: antidiabetic drugs as anticancer agents.Molecular biomedicine · 2024Review
- International regulatory and publicly-funded initiatives to advance drug repurposing.Frontiers in medicine · 2024Article
- Pathways for non-manufacturers to drive generic drug repurposing for cancer in the U.S.Frontiers in pharmacology · 2024Article
- Time to Deliver on Promises: The Role of ERBB2 Alterations as Treatment Options for Colorectal Cancer Patients in the Era of Precision Oncology.Journal of personalized medicine · 2023Article
- Drug Repurposing of Generic Drugs: Challenges and the Potential Role for Government.Applied health economics and health policy · 2023Article
- Off-label despite high-level evidence: a clinical practice review of commonly used off-patent cancer medicines.ESMO open · 2023Review
- Emerging Perspectives on the Antiparasitic Mebendazole as a Repurposed Drug for the Treatment of Brain Cancers.International journal of molecular sciences · 2023Review
- [Authorization for off-label use may not be beneficial for the Brazilian Unified National Health System].Cadernos de saude publica · 2023Article
- Delivering precision oncology to patients with cancer.Nature medicine · 2022Review
- Drugs and biologics receiving FDA orphan drug designation: an analysis of the most frequently designated products and their repositioning strategies.Expert opinion on orphan drugs · 2022Article
Corrections and comments
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Repurposing of medicines has gained a lot of interest from the research community in recent years as it could offer safe, timely, and affordable new treatment options for cancer patients with high unmet needs. Increasingly, questions arise on how new uses will be translated into clinical practice, especially in case of marketed medicinal products that are out of basic patent or regulatory protection. The aim of this study was to portray the regulatory framework relevant for making repurposed medicines available to cancer patients in Europe and propose specific policy recommendations to address the current regulatory and financial barriers. We outlined two routes relevant to the clinical adoption of a repurposed medicine. First, a new indication can be approved, and thus brought on-label,
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