On-Label or Off-Label? Overcoming Regulatory and Financial Barriers to Bring Repurposed Medicines to Cancer Patients
Drug repurposing holds the promise of accelerating access to safe and affordable treatment options, especially for patients with rare, pediatric, or neglected diseases.
Even though various regulatory pathways already exist to make repurposed medicines available to cancer patients, important challenges occur in bringing new uses on-label.
To address current challenges, we encourage the development of a European collaborative framework in which academic and not-for-profit organisations, pharmaceutical industry, health technology assessment bodies, payers, and regulators can work together on developing new uses for marketed medicines.
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, via the marketing authorisation procedures established in European and national legislation. A second option is to prescribe a medicine off-label for the new indication, which is managed at the national level in Europe.
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