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RLT Institute
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Foundations of theranostics

Radioligand therapy (RLT) and radioligand imaging (RLI) offer a novel, theranostic approach to targeting and treating certain types of cancer.1 This section of the Novartis RLT Institute is designed to help health care professionals (HCPs) understand the basic scientific foundations of RLT. By focusing on the science, we aim to demystify radiation and safety concerns and build confidence in offering patients this approach to precision medicine in cancer.

Radiation safety fundamentals

Regulation of RLT safety

An icon of safety caution.

In facilities that utilize RLTs, the ownership, use, receipt, and transfer of radioactive materials are governed by national and state laws. These rules and guidelines enable compliance through licensing, overseen by institutional committees and regulatory agencies, to uphold safety standards and proper management of RLTs.2-6

National agencies

US agencyFunction related to RLT
US Food and Drug Administration (FDA)2
  • Evaluates and approves drugs and devices based on safety and efficacy
Nuclear Regulatory Commission (NRC)2,4-6
  • Establishes safety standards and issues licenses for the medical use of radioactive material (RAM), including RLTs
  • Oversees training and requirements for HCPs to become authorized users (AUs)
  • Regulates the packaging, transport, receipt, and processing of RLTs
US Department of Transportation (DOT)3
  • Governs the shipping of RLTs and transport of treatment waste materials, which are packaged in specialized boxes
International Air Transport Association (IATA)3
  • Oversees the air transport of hazardous materials internationally, including RAM (eg, RLTs)
  • Outlines standards for the preparation, acceptance, and handling of dangerous goods

State agencies

  • State regulation of RLT varies and may fall under a state’s Department of Public Health, Environmental Protection, or Radiation Control2,7
  • Over 75% of states, known as Agreement States, have signed agreements with the NRC to assume regulatory authority, while the NRC retains authority in Non-Agreement States7
ALARA principle
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