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PET Drug Development Streamlining Proposal Gets Thumbs Up From US FDA Panel

 
• By Sue Sutter

New approach that would eliminate the need for animal dosimetry data for some positron emission tomography drugs draws advisory committee support, although some panelists raise concerns about limited existing data and longer half-life for copper 64, one of the six radionuclides under consideration.

Get out of jail card
FDA's plan aimed at reducing burden on PET imaging drug sponsors is not a get out of jail free card, one adcomm member observed. • Source: Shutterstock

A US Food and Drug Administration advisory committee generally supported a proposal that would eliminate the need for animal dosimetry data for some new positron emission tomography (PET) drugs, although several panelists questioned whether sufficient data were available to justify this approach for one of the six radionuclides at issue.

Radionuclides Targeted For Streamlined Development

  • 18F (flourine)

  • 11C (carbon)

  • 68Ga (gallium)

  • 64Cu (copper)

The Medical Imaging Drugs Advisory Committee convened on 1 August to discuss an agency proposal to use the mean administered activity (AA) values from approved product labeling as a guideline for first-in-human

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